[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"obesity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:obesity":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,786,0,25,[9,45,81,106,127,157,180,204,223,253,277,294,306,315,337,347,368,395,423,449,477,501,527,550,570],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053897","understanding-metabolism-and-inflammation-risks-for-diabetes-in-adolescents-100053897",false,"NCT06007404","Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents","The Role of Circulating Meta-Inflammatory Monocytes in Adolescent Insulin Resistance","Inclusion Criteria:\n\n* Between 14 and 18 years of age\n* Tanner stage 4 or 5 (mature adult stage of puberty)\n* Normal weight (BMI ≥ 5th percentile \\& \\\u003C 85th percentile), overweight (BMI \\> 86th percentile) \\& \\\u003C 94th percentile), obese weight (BMI percentile ≥ 95th percentile), and\u002For pre-diabetes (HbA1c \\> 5.7%)\n* For Type 2 Diabetes cohort, diagnosis of Type 2 Diabetes\n\nExclusion Criteria:\n\n* Currently pregnant\n* Use medications known to affect glucose metabolism (immunosuppressive medications, cancer medications, or high dose steroids), unless prescribed for Type 2 Diabetes management\n* Prior diagnosis of autoimmune disease, cancer, or a cognitive or perceptual disability that would inhibit following directions of study staff\n* Allergies or intolerance to milk, soy, or palm oil",true,"ALL","14 Years","18 Years",{"count":22,"type":23},175,"ESTIMATED","OBSERVATIONAL","This research study collects health-related information and blood samples to better understand how body composition, lifestyle habits, and diet influence meta-inflammatory monocytes (MiMos) in adolescents. The hypothesis of this study is that adolescents at risk for metabolic disease have enhanced MiMo related activities leading to insulin resistance.",[27,28,29,30,31],"Type 2 Diabetes","Insulin Resistance","Obesity","Metabolic Disease","PreDiabetes","RECRUITING","2026-07-10",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":36},"2023-09-06",{"date":40,"type":23},"2027-09",{"name":42,"class":43},"University of Michigan","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":18,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":68,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100053567","early-phase-1-team-based-shared-decision-making-program-in-cardiovascular-kidney-metabolic-health-100053567","NCT07662616","Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health","Feasibility and Efficacy Pilot of a Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health, Medication Adherence, and Cardiovascular Health","SDM in CKM","Inclusion Criteria:\n\n* Are adults aged 30 to 79 years (to use PREVENT equations to calculate 10- and 30-year risk estimates for total CVD),\n* Are in stage 2 CKM: the presence of metabolic risk factors (hypertension \\[stages 1 and 2\\], hypertriglyceridemia \\[≥135 mg\u002FdL\\], diabetes, Metabolic Equivalents (MetS)\\*) and\u002For Chronic Kidney Disease (CKD) \\[moderate- to high-risk CKD which are stages 1-3 CKD\\]), and\n* Receive primary care at Johns Hopkins Community Physicians (JHCP).\n* Access to smart phone or tablet to use app.\n\nExclusion Criteria:\n\n* Have diagnosis of CVD,\n* Stage 4-5 CKD, kidney failure, or on dialysis\n* Have a serious medical condition such as cancer;\n* On or planning to start Glucagon-like peptide-1 (GLP-1) receptor agonists in next 6 months;\n* Have cognitive impairment;\n* Are currently involved in other programs on improving LE8; or\n* Unwillingness to provide informed consent\n* Unable to speak, read, or communicate in English.","30 Years","79 Years",{"count":56,"type":23},94,"INTERVENTIONAL",[59],"EARLY_PHASE1","The investigators are proposing a new team-based shared decision-making (SDM) program. The goal of this study is to see whether this program is practical and whether it may help adults with cardiometabolic risk factors and cardiovascular-kidney-metabolic syndrome. The investigators will enroll adults from a primary care clinic in Maryland. People in the intervention group will take part in the 6-month program in addition to usual care. People in the control group will receive usual care only.",[62,63,64,65,29,66,67],"Hypertension (HTN)","Diabetes (DM)","Hyperlipidaemia","Kidney Disease","Cardiovascular-kidney-metabolic (CKM)","Overweight",[69,70,71,72],"shared decision-making","Cardiovascular-kidney-metabolic","Behavioral counseling","Team-based care","NOT_YET_RECRUITING",{"date":35,"type":36},{"date":76,"type":23},"2026-08-10",{"date":78,"type":23},"2028-06-30",{"name":80,"class":43},"Johns Hopkins University",{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":17,"sex":18,"minAge":20,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":57,"phases":91,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":44},"100053438","phase-2-trial-of-the-combination-of-alpha-lipoic-acid-and-mirabegron-in-women-and-in-men-with-obesity-100053438","NCT05713799","Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity","Phase II Trial of the Combination of Alpha-lipoic Acid and Mirabegron in Women and in Men With Obesity","* INCLUSION CRITERIA\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Adults 18 to 65 years of age\n2. BMI greater than or equal to 30 kg\u002Fm\\^2 and less than or equal to 45 kg\u002Fm\\^2\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Hypersensitivity and associated allergic reactions to mirabegron or alpha-lipoic acid (or similar drug substances or components).\n2. Abnormal bladder function, diagnosis of bladder outlet obstruction, urgency, and urinary frequency or use of antimuscarinic medication to treat overactive bladder (OAB).\n3. Type 1 diabetes mellitus; type 2 diabetes mellitus; or any person taking exogenous insulin therapy or any medication that is a hypoglycemic agent. (type 1 or Type 2 Diabetes mellitus, fasting serum glucose \\>125 mg\u002FdL, and\u002For an HbA1c test \\>6.5%).\n4. Elevated resting blood pressure \\>140\u002F90 mmHg.\n5. Individuals with eGFR \\\u003C60 ml\u002Fmin\u002F1.72 m\\^2 and a urinary albumin\u002Fcreatinine ratio UACR\\>300 mg\u002Fg.\n6. Hypo- or hyper-thyroid disease (TSH \\>5.0, or \\\u003C0.4 MIU\u002FL) that is controlled for less than one year or someone currently taking thyroid hormone replacement.\n7. Anemia, defined by hemoglobin \\\u003C11.5 g\u002FdL (females) or \\\u003C13.5 g\u002FdL (males); sickle cell anemia or other blood disorders; and\u002For wound healing problems.\n8. Cardiovascular disease, cardiac arrhythmias, orthostasis, unstable vasomotor system, or renal impairment.\n9. A clinically significant abnormal ECG and\u002For QTc interval above normal\n10. Moderate hepatic impairment (Child-Pugh Class B) or above\n11. Elevated liver enzymes \\>75 U\u002FL (ALT or AST)\n12. Recent history in last 4 weeks of any local or systemic infectious disease with fever or requiring antibiotics\n13. Pregnancy, childbirth within the last year, or breastfeeding in the past 12 months.\n14. Individuals that have been on a very low-calorie diet (\\\u003C800 kcal\u002Fd), self-reported weight loss \\>5% in the preceding six months, or those taking weight loss medications.\n15. History of seizure disorder.\n16. Addiction to alcohol or substances of abuse within the last 5 years.\n17. Self-reported current alcohol consumption of more than 2 servings of alcohol per day.\n18. Self-reported current use of nicotine and\u002For tobacco products.\n19. Current use of any drugs known to:\n\n    1. Have major drug-drug interactions with mirabegron or alpha-lipoic acid\n    2. Be CYP2D6 substrates\n    3. Prolong QT interval\n    4. Alter glucose metabolism or cause insulin resistance (in last six months)\n    5. Treat diabetes mellitus\n    6. Treat hypertension\n    7. Be drugs of abuse\n20. Inability to provide informed consent.\n21. Unwilling or unable to eat metabolic meals, as determined by dietitian consult.\n22. Individuals with significant medical comorbidities or other factors that would render the individual s participation unsafe or affect the outcome of the study as assessed by the investigator.","65 Years",{"count":90,"type":23},60,[92],"PHASE2","Background:\n\nObesity and related illnesses cause at least 2.8 million deaths each year worldwide. Few treatments exist for obesity that are safe and widely available. A study drug (mirabegron \\[MG\\]) combined with a supplement (alpha-lipoic acid \\[ALA\\]) may help.\n\nObjective:\n\nTo learn how MG and ALA can help the body process food.\n\nEligibility:\n\nPeople aged 18 to 65 years with a body mass index between 30 and 45 kg\u002Fm2.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam. They will have blood and urine tests and a test of their heart function. They will speak with a dietician.\n\nThe study has two phases. Each phase begins with a 2-day stay in the clinic; then the participant will take the study drugs at home for about 4 weeks, followed by another 2-day stay in the clinic. They will also have outpatient visits about 2 weeks after each clinic stay.\n\nDuring the clinic stays, participants will undergo many tests:\n\nThey will have a plastic tube (catheter) inserted into a vein in each arm. These will be used to draw blood and to infuse glucose (sugar) and insulin.\n\nThey will have imaging scans.\n\nThey will have a clear hard plastic shield placed over their head to measure oxygen and carbon dioxide as they breathe.\n\nParticipants will take the study drugs at home. Both MG and ALA are taken by mouth with water. During one phase, participants will take MG plus a placebo. A placebo looks like the study drug but doesn t contain medicine....",[28,29],[29,96,28,97],"Insulin Sensitivity","Placebo",{"date":35,"type":36},{"date":100,"type":23},"2026-07-16",{"date":102,"type":23},"2030-03-01",{"name":104,"class":105},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":18,"minAge":112,"maxAge":88,"enrollmentInfo":113,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":124,"leadSponsor":126,"locationsCount":44},"100053739","evaluation-of-the-clinical-spectrum-of-diabetes-and-obesity-in-youth-and-adults-100053739","NCT07388537","Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Age 8 years to 65 years\n2. Meet at least one of the following:\n\n   a. Overweight\u002FObesity:\n\n   i. For participants under 18 years of age: BMI \\>= 85th percentile for age and sex\n\nii. For participants \\>= 18 years of age: BMI \\>= 25 kg\u002Fm\\^2 (\\>=23 kg\u002Fm\\^2 for self-reported Asian race\u002Fethnicity)\n\nb. Suspected or evidence of hyperglycemia:\n\ni. Diagnosis of prediabetes or diabetes in medical history or by participant\u002Fguardian\u002FLegally Authorized Representative (LAR) report, OR\n\nii. Fasting blood glucose \\>= 100 mg\u002FdL in medical record, OR\n\niii. Postprandial blood sugar \\>= 140 mg\u002FdL in medical record, OR\n\niv. Hemoglobin A1c \\>= 5.7% in medical record\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. History of significant medical illnesses that the investigators feel may interfere with potential evaluations, i.e. individuals who are critically ill, unstable, or with severe organ failure that may affect\u002Flimit the endocrine evaluation and place unsustainable demands on Clinical Center or NIDDK resources.\n2. History of any medical, psychiatric, or social conditions which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the participant.\n3. Inability or unwillingness of participant, parent\u002Fguardian, or LAR to provide informed consent.","8 Years",{"count":114,"type":23},1000,"Background:\n\nDiabetes and obesity are chronic diseases. They can affect blood flow and how the body processes nutrients, and complications over time can lead to early death. Diabetes can affect children as well as adults, but the disease seems to be more severe and to progress faster when it appears in younger people. Researchers want to understand more about how diabetes and obesity develop and change over time.\n\nObjective:\n\nTo collect data and samples regularly from people with obesity and diabetes.\n\nEligibility:\n\nPeople aged 8 to 65 years. They must be overweight or obese; or have high blood sugar; or have problems with how their body uses food for energy.\n\nDesign:\n\nParticipants will have additional procedures during routine care visits at the NIH clinic.\n\nData collected for the study will include the following:\n\nInformation from the participant s medical chart will be kept for research.\n\nQuestionnaires will ask about participant s eating habits, feelings, sleep, and substance use. They will take 30 to 60 minutes. Care providers will address any issues revealed in these surveys.\n\nBlood, saliva, urine, and stool samples will be collected. Samples may be used for genetic tests.\n\nData and samples will be kept for future research.\n\nParticipants may remain in the study up to 30 years.",[29,117,118],"Diabetes","Metabolic Disorders",[120,29,121,30],"Clinical Spectrum of Diabetes","Hyperglycemia",{"date":35,"type":36},{"date":100,"type":23},{"date":125,"type":23},"2055-04-30",{"name":104,"class":105},{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":88,"enrollmentInfo":135,"targetDuration":4,"studyType":57,"phases":137,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},"100053367","phase-4-ai-assisted-lifestyle-intervention-versus-tirzepatide-for-obesity-and-newly-diagnosed-type-2-diabetes-100053367","NCT07697391","AI-Assisted Lifestyle Intervention Versus Tirzepatide for Obesity and Newly Diagnosed Type 2 Diabetes","A Multicenter Randomized Controlled Trial Evaluating AI-Assisted Intensive Lifestyle Intervention Versus Tirzepatide for Glycemic and Weight Management in Patients With Obesity and Newly Diagnosed Type 2 Diabetes","AI-LIFE-T2D-OB","Inclusion Criteria:\n\n1. Male or female participants aged 18 to 65 years.\n2. Newly diagnosed type 2 diabetes mellitus, defined as diagnosis within 3 years and no use of glucose-lowering medications within the past 3 months. Diagnosis should meet the 1999 World Health Organization criteria, including at least one of the following: random plasma glucose ≥11.1 mmol\u002FL, fasting blood glucose ≥7.0 mmol\u002FL, 2-hour postprandial blood glucose ≥11.1 mmol\u002FL, or HbA1c ≥6.5% and ≤10.0%. Participants without typical diabetes symptoms should have repeat testing for confirmation.\n3. Body mass index ≥28 kg\u002Fm² and \\\u003C40 kg\u002Fm².\n4. Willing to use effective contraception and have no pregnancy plan within 12 months after signing the informed consent form; female participants must have a negative pregnancy test at screening.\n5. Able to communicate with the investigators, willing to comply with the study protocol, and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Type 1 diabetes mellitus, type 2 diabetes requiring insulin treatment, or other specific types of diabetes.\n2. Body weight change \\>5% within 12 weeks before screening.\n3. Pregnant or breastfeeding women.\n4. Severe trauma, severe infection, or surgery within 1 month before screening that may affect glycemic control.\n5. Severe cardiovascular or cerebrovascular events within 6 months before screening, including angina, myocardial infarction, arrhythmia, cerebral infarction, cerebral hemorrhage, or other clinically significant events.\n6. History of acute or chronic pancreatitis, history of pancreatic injury, or amylase \\>1.5 × upper limit of normal at screening.\n7. Current or previous malignancy, except local basal cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the prostate; diagnosis of malignancy within 5 years before screening.\n8. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, or history of thyroid nodules.\n9. Blood dyscrasia or any disease causing hemolysis or unstable red blood cells, or hemoglobinopathy that may affect HbA1c measurement.\n10. History of organ transplantation or acquired or congenital immune system disease.\n11. Schizophrenia or other psychiatric disorder that may interfere with participation in the study.\n12. Unstable or treatment-requiring endocrine disease related to glycemic control, such as hyperthyroidism, acromegaly, or Cushing syndrome, as judged by the investigator.\n13. Hypertension with systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>90 mmHg after stable antihypertensive treatment.\n14. Clinically significant abnormal gastric emptying, severe chronic gastrointestinal disease, diabetic gastroparesis, long-term use of medications directly affecting gastrointestinal motility, or history of gastrointestinal surgery.\n15. Special dietary requirements or allergy to foods such as soy products or dairy products.\n16. Use of medications affecting glucose regulation within 3 months before randomization, such as glucocorticoids, growth hormone, thyroid hormone, sex hormones, cyclosporine, or phenytoin.\n17. Allergic constitution, defined as allergy to two or more categories of substances.\n18. Fasting C-peptide \\\u003C0.81 ng\u002FmL.\n19. Calcitonin ≥50 pg\u002FmL.\n20. Abnormal laboratory results, including AST or ALT \\>2.5 × upper limit of normal, bilirubin \\>2.5 × upper limit of normal, triglycerides ≥5.7 mmol\u002FL, estimated creatinine clearance \\\u003C60 mL\u002Fmin using the Cockcroft-Gault formula, or clinically significant anemia with hemoglobin \\\u003C120 g\u002FL in men or \\\u003C110 g\u002FL in women.\n21. Unstable proliferative retinopathy or maculopathy requiring urgent treatment within 1 year before randomization, or history of diabetic ketoacidosis, hyperosmolar nonketotic coma, or severe metabolic disorder causing neuropsychiatric dysfunction.\n22. History or risk factors of epilepsy, syncope, cardiac arrest, arrhythmia, atrioventricular block, structural heart disease, torsades de pointes, hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, or hypocalcemia.\n23. Active bacterial, viral, or fungal infection requiring hospitalization or intravenous antibiotic treatment.\n24. Positive HBsAg, HCV antibody, HIV antibody, or Treponema pallidum antibody.\n25. Positive urine drug screening and\u002For drug dependence.\n26. Participation in another clinical trial within 3 months before enrollment or current participation in another drug or device clinical trial.\n27. Any other condition that, in the investigator's opinion, makes the participant unsuitable for this study.",{"count":136,"type":23},285,[138],"PHASE4","This multicenter randomized controlled trial will evaluate whether an AI-assisted intensive lifestyle intervention can improve weight and glycemic management in adults with obesity and newly diagnosed type 2 diabetes, compared with tirzepatide treatment and standard lifestyle management. Eligible participants will be adults aged 18 to 65 years with a body mass index of 28 to less than 40 kg\u002Fm² and newly diagnosed type 2 diabetes who have not used glucose-lowering medications in the past 3 months.\n\nParticipants will be randomly assigned to one of three groups: an AI-assisted intensive lifestyle intervention group, a tirzepatide treatment group, or a standard lifestyle management control group. The intervention period will last 52 weeks, followed by a 12-week post-intervention follow-up period. The main outcome is the percentage change in body weight at week 52. The study will also assess glycemic control, body composition, continuous glucose monitoring metrics, safety, and other metabolic outcomes.",[29,141],"Diabetes Mellitus, Type 2",[143,144,145,146,147,148],"AI-Assisted Lifestyle Intervention","Tirzepatide","Weight Management","Glycemic Control","Continuous Glucose Monitoring","Randomized Controlled Trial",{"date":35,"type":36},{"date":151,"type":23},"2026-07-20",{"date":153,"type":23},"2028-01-31",{"name":155,"class":43},"The First Affiliated Hospital of Anhui Medical University",2,{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":18,"minAge":163,"maxAge":164,"enrollmentInfo":165,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":167,"conditions":168,"keywords":169,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":176,"leadSponsor":178,"locationsCount":44},"100053485","a-natural-history-of-genetic-and-environmental-predictors-of-pubertal-timing-among-youth-with-obesity-100053485","NCT07437976","A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study, including sharing medical records\n2. Male or female, aged 5 to 7 years at the screening visit\n3. Normal weight (defined as BMI \\> 5th percentile and \\\u003C85th percentile for age and sex) or Obese weight (defined as BMI \\> 95th percentile for age and sex)\n4. Ability of parent or guardian to understand and willingness to sign a written informed consent document. And ability of the participant (child) to provide verbal assent and\u002For to sign a written assent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Known diagnosis of syndromic\u002Fgenetic form of obesity\n2. Current use of medications or supplements that affect reproductive hormones (e.g., estrogen, progesterone, testosterone, puberty blockers, regular use of lavender oil or tea tree oil)\n3. Chronic medical conditions (e.g., type 1 or type 2 diabetes, cancer, renal failure, lupus, etc.), at the discretion of the Principal Investigator\n4. Clinically significant abnormal laboratory values, at the discretion of the Principal Investigator\n5. International adoptee (associated with earlier puberty)\n\nIndividuals who do not meet the criteria for participation in this study (screen failure) because of an acute, reversible or transient medical reason may be rescreened upon reversal, improvement or stabilization of their clinical status. Participants who develop an acute, reversible or transient medical condition during the study may return upon reversal, improvement or stabilization of their clinical status.","5 Years","12 Years",{"count":166,"type":23},400,"Background:\n\nObesity affects 1 in 5 children in the United States. Childhood obesity often persists into adolescence and adulthood. It can also raise the risk of sleep apnea, fatty liver disease, and fluid buildup in the brain and lead to early-onset puberty. This natural history study will explore how factors such as genes, hormones, diet, and chemical exposures affect puberty in children with obesity.\n\nObjective:\n\nTo learn which factors predict the early start of puberty in children with obesity vs those of normal weight.\n\nEligibility:\n\nChildren aged 5 to 7 years with obesity or of normal weight.\n\nDesign:\n\nParticipants will have clinic visits every 6 months until they reach age 12.\n\nEach clinic visit will include these tests and procedures:\n\nA physical exam.\n\nCollection of blood, urine, and saliva samples. Some samples will be used for genetic tests.\n\nQuestions about medical history and medications and supplements.\n\nA questionnaire about their physical activity over the previous week.\n\nA silicone wrist band. Participants will wear a soft wristband for a week prior to each visit. It will tell researchers what chemicals the children were exposed to during that time.\n\nBreast ultrasound, for girls. A gel will be applied, and a wand will be pressed against the skin. The wand uses sound waves to see the tissue inside the breast.\n\nDXA whole body scan. Once a year, participants will have a DXA (dual energy X-ray absorptiometry) scan. This scan measures the amount of bone, muscle, and fat in the body.\n\nOptional food diary. Parents may record everything the participant eats for two 24-hour periods\n\n...",[29],[170,29,171,172,173],"ADRENARCHE","Reproductive Hormones","Puberty","Environmental predictors",{"date":35,"type":36},{"date":100,"type":23},{"date":177,"type":23},"2036-12-23",{"name":179,"class":105},"National Institute of Environmental Health Sciences (NIEHS)",{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":57,"phases":189,"briefSummary":191,"conditions":192,"keywords":193,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":44},"100053884","diet-order-effects-of-low-fat-vs-low-carb-diets-on-body-fat-change-100053884","NCT06325722","Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study\n2. Adults aged 18-50 years\n3. Weight stable (\\\u003C +\u002F- 5% over past 6 months) as determined by volunteer report\n4. Body mass index (BMI) \\>= 25 kg\u002Fm\\^2\n5. Agreement to adhere to Lifestyle Considerations throughout the study duration\n\nEXCLUSION CRITERIA:\n\n1. Subjects with cardiac pacemakers or other implants that may be affected by or affect the DXA measurements\n2. Inadequate access to equipment required for the study (e.g., too little refrigerator storage space or a microwave oven that is too small) as determined by discretion of PI and\u002For study team\n3. Evidence of diseases or conditions that may influence appetite (e.g., cancer, diabetes, alterations of smell or taste post COVID-19), diseases or conditions that affect the immune system, or other conditions at the discretion of the PI and\u002For study team\n4. Taking prescription medications or other drugs that may influence metabolism (including but not limited to diet\u002Fweight-loss medication, some psychiatric medications, or other medications at the discretion of the PI and\u002For study team)\n5. People unlikely to adhere to a relatively consistent daily and weekly routine and avoid travel during their participation in the study. For example, people with occupations such as pilots, flight attendants, or frequently travel for work or pleasure.\n6. People unlikely to abstain from off study food or supplements that may impact metabolism or appetite at the discretion of the study team\n7. Positive pregnancy test or lactating as determined by volunteer report (women only)\n8. Inability or unwillingness to use birth control between screening and completion of the study (women only)\n9. Symptoms or signs of perimenopause or menopause by volunteer report (women only)\n10. Regular vigorous exercise \\>150 min per week as determined by volunteer report\n11. Alcohol consumption \\> 3 drinks per day as determined by volunteer report\n12. Regular use of tobacco (smoking, chewing, or vaping), nicotine replacement therapy, or illicit drugs over past 6 months as determined by volunteer report. Subjects may also be excluded based on a urine drug test.\n13. Psychological conditions as determined by DSM-5 Self-rated Level 1 Cross-cutting Symptom Measure such as (but not limited to) eating disorders, depression, bipolar disorders, that would be incompatible with safe and successful participation in this study, as determined by investigators\n14. Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies) or a reported dislike of a significant fraction of the study foods\n15. Volunteers unwilling or unable to give informed consent\n16. Non-English speakers due to unavailability of required questionnaires in other languages\n17. Resting Energy Expenditure test result within 10% of the 2500 calorie requirement at rest","50 Years",{"count":188,"type":23},42,[190],"NA","Background:\n\nIn a previous study, participants were lived at the NIH and randomly received either a low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2 more weeks. Participants who received the low-carbohydrate diet first lost more body fat at the end of the study than those who received the low-fat diet first. Researchers want to see if they can repeat that result in a longer weight loss study when participants live at home.\n\nObjective:\n\nTo test the effects of diet order in people receiving either a low-fat or low-carbohydrate diet first for 4 weeks and then immediately switched to the other diet for another 4 weeks.\n\nEligibility:\n\nAdults aged 19 to 50 years with a body mass index of 25 or more.\n\nDesign:\n\nParticipants will complete the study at their homes, but there will be 3 required visits to the NIH. Participants will drink a special type of water 2 weeks before the baseline NIH visit and collect urine samples at home to measure how many calories they burn. Before the diets begin, participants will visit the NIH for baseline testing when they will have a metabolism test while relaxing in a bed with a plastic hood over their head to collect the air they breathe out. They will have scans to measure their bone density and how much muscle and body fat they have. They will give stool, blood, and urine samples.\n\nParticipants will be asked to eat a specific diet for 4 weeks followed by a different diet for 4 weeks. All meals will be delivered to the participants' homes. They will eat only the foods delivered.\n\nParticipants will weigh themselves daily. They will wear a monitor to track their physical activity and a sensor to measure their glucose levels. They will prick their finger each morning to test a drop of blood for ketones. Participants will meet virtually as a group with the study team weekly. Participants will have two more NIH visits towards the end of each diet period....",[67,29],[194,195,196,197],"Diet","Body Fat","Nutrition","weight-loss",{"date":35,"type":36},{"date":200,"type":36},"2024-08-28",{"date":202,"type":23},"2029-11-30",{"name":104,"class":105},{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":17,"sex":18,"minAge":210,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":44},"100053428","identification-of-phenotypic-factors-that-predict-success-for-weight-loss-and-long-term-weight-maintenance-100053428","NCT02043457","Identification of Phenotypic Factors That Predict Success for Weight Loss and Long-term Weight Maintenance","Inclusion Criteria:\n\n* Obese males and females: age \\>20 years; Obese population defined as BMI \\> or = 27 kg\u002Fm2\n* Lean population BMI \\\u003C 27 but \\> 17 kg\u002Fm2\n* Able and willing to provide written informed consent for the trial\n\nExclusion Criteria:\n\n* Evidence of inherited disorders of lipid metabolism.\n* History of Cancer within the last 5 years\n* Human immunodeficiency virus (HIV) antibody positive.\n* Patients with solid organ transplants.\n* Participation in any other clinical trial within 90 days of entry into this trial.\n* Pregnant or lactating females.\n* Uncontrolled thyroid disease\n* Unstable angina or NY heart association class II failure or above\n* Gastrointestinal disease specifically GI motility disorders\n* Unstable neuropsychiatric disease including major depression\u002Fanxiety, eating disorder such as binge eating, bulimia or anorexia\n* End stage renal or hepatic disease\n* Autoimmune disorders (e.g. SLE)\n* Body weight fluctuation of more than 5 kg in the previous 3 months\n* Prior bariatric surgery\n* A history or current alcohol\u002Fsubstance abuse and change in smoking habits or cessation in the past 6 months.\n* Women of childbearing age must use a reliable form of contraception.\n* Any medical condition, which in the opinion of the investigator would make the patient unsuitable for recruitment, or could interfere with the patient participating in or completing the protocol.\n* Unwilling or unable to consent for the study.","15 Years","75 Years",{"count":213,"type":23},3200,"The Investigational Weight Management Clinic now entitled the Weight Management Program at the University of Michigan was created to identify strategies that will result in cost-effective, long term weight management for overweight and obese individuals. The driving hypothesis of the clinic is that the 'one size fits all' philosophy is untenable with a complex disease such as obesity. The clinic will serve as a portal for patients to choose standard clinical care or to explore alternatives from a variety of clinical studies offered through the clinic. These studies will include further investigations into nutrition, the biological basis of weight and weight management and protocols using approved and experimental pharmaceuticals as well as technologies that aid in self-management of weight.",[29],"2026-07-09",{"date":35,"type":36},{"date":219,"type":4},"2009-08",{"date":221,"type":23},"2030-12",{"name":42,"class":43},{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":230,"minAge":20,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":57,"phases":233,"briefSummary":234,"conditions":235,"keywords":241,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":44},"100053713","facilitated-transitions-from-postpartum-to-primary-care-coordination-for-people-with-chronic-conditions-100053713","NCT06557005","Facilitated Transitions From Postpartum to Primary Care Coordination for People With Chronic Conditions","Bridges to Primary Care: Transforming Postpartum Primary Care Coordination for People With Chronic Conditions","Inclusion Criteria\n\n* Receiving obstetric care at an MGH-affiliated obstetrics practice (except for the MGH HOPE Clinic, which has a unique care model that provides prenatal and postnatal care for individuals with substance use disorder, including the provision of primary care through 2+ years postpartum)\n* Pregnant with a live fetus or delivered a live-born neonate ≥24 weeks of gestation, based on the clinical estimate of gestational age\n* If postpartum, has a neonate that is currently living at the time of enrollment\n* Has one or more of the following conditions listed in the \"Problem List,\" \"Medical History,\" or clinical notes during prenatal, intrapartum, or postpartum encounters in the EHR (or in the case of BMI, the patient's anthropometric measurements):\n\n  * Chronic or essential hypertension\n  * Hypertensive disorders related to pregnancy (e.g., pre-eclampsia)\n  * Type 1 or 2 diabetes (i.e., pre-existing diabetes)\n  * Gestational diabetes\n  * Class II Obesity (pre-pregnancy body mass index ≥35 kg\u002Fm2; or if pre-pregnancy body mass index is not known, a first trimester BMI of ≥35 kg\u002Fm2)\n  * Depression or anxiety disorder\n* Has a primary care clinician listed in the patient's medical record\n* Has access to or agrees to be enrolled in the electronic health record patient portal and consents to be contacted via these modalities\n* Able to read\u002Fspeak English or Spanish language\n* Is age ≥18 years old\n\nExclusion Criteria\n\n• Any individual not meeting all inclusion criteria","FEMALE",{"count":232,"type":23},1320,[190],"The lack of postpartum primary care coordination is a missed opportunity to increase primary care engagement and manage chronic conditions early in life, especially for the \\>30% of pregnant people who have or are at risk for these conditions. This study aims to increase postpartum primary care engagement, quality, and experience by strengthening postpartum transitions to primary care using a behavioral economics-informed, multi-component intervention integrated into usual inpatient postpartum care. Using a randomized controlled trial and repeated outcome assessments through administrative and survey data, this study will generate rigorous, actionable evidence to ensure primary care coordination becomes standard postpartum care practice, potentially catalyzing sustained primary care engagement throughout life.",[236,117,237,238,239,240,29],"Hypertension","Postpartum","Pregnancy","Anxiety","Depression",[242,243,244,245],"Postpartum Care","Primary Care","Care Transitions","Chronic Disease",{"date":35,"type":36},{"date":248,"type":36},"2025-05-23",{"date":250,"type":23},"2028-05-23",{"name":252,"class":43},"Massachusetts General Hospital",{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":57,"phases":263,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":276},"100053553","phase-3-amaze-3-a-research-study-investigating-how-well-the-medicine-nnc0487-0111-helps-people-with-excess-body-weight-and-obstructive-sleep-apnoea-not-treated-with-positive-airway-pressure-lose-weight-and-improve-sleep-apnoea-100053553","NCT07571005","AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea","Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure (AMAZE 3)","AMAZE 3","Key Inclusion Criteria:\n\n* Male or female (sex at birth)\n* Age 18 years or above at the time of signing informed consent\n* Previously diagnosed moderate-to-severe OSA with an AHI ≥ 15, as diagnosed with polysomnography (PSG), home sleep apnoea test (HSAT), or other method that meets local guidelines prior to screening\n\nKey Exclusion Criteria:\n\n* Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol\u002Fmol) as measured by the central laboratory at screening\n* History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records\n* Any planned or previous surgery within 90 days prior to screening for sleep apnoea, including septoplasty, turbinoplasty, or other ear, nose, and throat surgeries, including tonsillectomy and adenoidectomy\n* Significant craniofacial abnormalities that may affect breathing at baseline, for example Treacher Collins syndrome and Pierre Robin Sequence\n* Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonist (RA), dual GLP-1\u002Fgastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening",{"count":262,"type":23},300,[264],"PHASE3","This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with excess body weight and obstructive sleep apnoea not treated with positive airway pressure lose weight and improve sleep apnoea. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.",[29,67,267],"Obstructive Sleep Apnoea",{"date":35,"type":36},{"date":270,"type":36},"2026-05-05",{"date":272,"type":23},"2028-10-04",{"name":274,"class":275},"Novo Nordisk A\u002FS","INDUSTRY",80,{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":57,"phases":285,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":288,"startDateStruct":289,"completionDateStruct":290,"leadSponsor":292,"locationsCount":293},"100054210","phase-3-amaze-4-a-research-study-investigating-how-well-the-medicine-nnc0487-0111-helps-people-with-excess-body-weight-and-obstructive-sleep-apnoea-treated-with-positive-airway-pressure-lose-weight-and-improve-sleep-apnoea-100054210","NCT07571109","AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea","Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Obstructive Sleep Apnoea Treated With Positive Airway Pressure (AMAZE 4)","AMAZE 4",{"count":262,"type":23},[264],"This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.",[29,67,267],{"date":35,"type":36},{"date":270,"type":36},{"date":291,"type":23},"2028-08-21",{"name":274,"class":275},92,{"id":295,"slug":4,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":18,"minAge":163,"maxAge":164,"enrollmentInfo":296,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":167,"conditions":297,"keywords":298,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":305,"locationsCount":44},"100626618",{"count":166,"type":23},[29],[170,29,171,172,173],"2026-07-01",{"date":301,"type":36},"2026-07-02",{"date":303,"type":23},"2026-07-07",{"date":177,"type":23},{"name":179,"class":105},{"id":307,"slug":4,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":18,"minAge":112,"maxAge":88,"enrollmentInfo":308,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":115,"conditions":309,"keywords":310,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":311,"startDateStruct":312,"completionDateStruct":313,"leadSponsor":314,"locationsCount":44},"100622816",{"count":114,"type":23},[29,117,118],[120,29,121,30],{"date":301,"type":36},{"date":303,"type":23},{"date":125,"type":23},{"name":104,"class":105},{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":17,"sex":18,"minAge":164,"maxAge":322,"enrollmentInfo":323,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":325,"conditions":326,"keywords":327,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":156},"100572195","youth-onset-type-2-diabetes-and-heart-disease-the-young-at-heart-prospective-cohort-study-100572195","NCT06730113","Youth-Onset Type 2 Diabetes and Heart Disease: The Young at Heart Prospective Cohort Study","Youth-onset Type 2 Diabetes and Heart Disease: The Young at Heart Prospective Cohort Study","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet the following criteria according to their group:\n\nFour categories of participants will be included in this study and the inclusion criteria for each group are given below:\n\n1. Participants with Y-T2DM\n\n1a.Age 12-25 years\n\n1b.Type 2 diabetes mellitus as defined by fasting blood glucose \\>= 126 mg\u002FdL OR postprandial blood sugar \\>= 200 mg\u002FdL OR Hemoglobin A1c \\>= 6.5% per American Diabetes Association Criteria and one element from the medical history consistent with ADA or AAP guidelines including: family history of diabetes and obesity, maternal or personal history of gestational diabetes, high-risk race and ethnicity, history of cardiovascular disease, hypertension, dyslipidemia, polycystic ovary syndrome, physical inactivity, other clinical conditions associated with insulin resistance (e.g. severe obesity, acanthosis nigricans, prediabetes), small or large for gestational age birth weight, history of breastfeeding, gestational history of illicit drugs including alcohol, smoking OR documentation of type 2 diabetes diagnosed at \\\u003C=25 years of age with verified medical history (as above).\n\n2\\. Youth with overweight\u002F obesity (Y-OW)\n\n2a. Age 12-25 years\n\n2b. For participants \\\u003C 18 years of age, BMI \\>= 85th percentile (overweight) and \\>= 95th percentile (obesity) for age and sex OR\n\n2c. For participants \\>= 18 years of age, BMI \\>=25\\\u003C30 kg\u002Fm\\^2 (overweight) or \\>=30 kg\u002Fm\\^2 (obesity)\n\n2d. Participants with obesity may have a diagnosis of prediabetes, defined as fasting blood glucose 100-125 mg\u002FdL OR postprandial blood sugar 140-199 mg\u002FdL OR HbA1c 5.7-6.4 percent (either during testing at NIH or as previously documented on outside medical record).\n\n3\\. Healthy control lean participants (Y-Lean)\n\n3a. Age 12-25 years\n\n3b. For participants \\\u003C 18 years of age, BMI \\\u003C= 85th percentile for age and sex OR\n\n3c. For participants \\>=18 years of age, BMI 18-24.99 kg\u002Fm\\^2.\n\n3d. HbA1c \\\u003C5.7 percent (either during testing at NIH or as previously documented on outside medical record).\n\n4\\. Biological parents of Y-T2DM, Y-OW and Y-Lean participants\n\n4a. Biological parent of enrolled Y-T2DM, Y-OW and Y-Lean by self-report.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria for their specific group will be excluded from participation in this study:\n\n1\\. Y-T2DM, Y-OW and Y-Lean Participants:\n\n1a. Type 1 diabetes or the presence of \\>2 diabetes auto-antibodies (e.g., GAD-65, IA-2 antigen, Zinc transporter 8 autoantibodies).\n\n1. b. Medical, psychiatric or cognitive disorders that will, in the opinion of the investigators, limit the subject s ability to comply with study procedures (specific obesity-related comorbidities are explicitly permitted, including hypertension, hyperlipidemia, obstructive sleep apnea and non-alcoholic steatohepatitis).\n\n1c. Serious medical illnesses or diseases thought to alter metabolism (including moderate to severe renal disease (\\\u003C 30 mL\u002Fmin\u002F1.73m\\^2), congenital heart disease, Cushing s syndrome, cancer, or other metabolic diseases associated with diabetes or excess weight).\n\n1d. For participants enrolled at the NIH, dietary allergies, intolerances or eating patterns that would preclude them from consuming metabolic meals.\n\n1e. Unwilling to comply with all study procedures or to adhere to Lifestyle Considerations throughout study duration.\n\n1f. Pregnancy at the time of the screening visit.\n\n1g. Clinically significant anemia OR Hematocrit below the lower limit of normal for age and sex cutoffs.\n\n1. h. For Y-OW Participants- Meet lab and medical history criteria for Y-T2DM as described in inclusion criterion 1b above.\n\n2\\. Y-Lean participants:\n\nIn addition to the above exclusion criteria, any Y-Lean participant who meets any of the following additional criteria will be excluded from the study:\n\n2a. Current use of prescription or non-prescription medication. Certain exceptions are permitted, including topical medications, vitamins, and hormonal contraceptives. Other medications may be permitted at the discretion of the investigators.\n\n2b. Recent (past 2 months) use of drugs or supplements that alter glucose or lipid metabolism (e.g., niacin, fish oil, red yeast rice)\n\n2c. History of diabetes or abnormal glucose tolerance\n\n2d.. Abnormal screening labs, including the following:\n\ni) ALT or AST \\>2 times the upper limit of normal\n\nii) Glycosuria\n\niii) Low eGFR (\\\u003C90 mL\u002Fmin\u002F1.73m\\^2)Any other abnormality that, in the opinion of the investigator, will increase risk to the subject from participation, or interfere with interpretation of study data\n\n2e. Meet lab and medical history criteria for Y-T2DM as described in inclusion criterion 1b above.\n\n3\\. Biological Parents\n\n-No Exclusion Criteria","25 Years",{"count":324,"type":23},930,"Background:\n\nType 2 diabetes is a disease that affects blood sugar levels. Complications can include heart and blood vessel (vascular) diseases. Rates of type 2 diabetes have tripled in children and young adults over the last 40 years. Vascular diseases are also increasing in young people.\n\nObjective:\n\nTo learn more about factors, including type 2 diabetes, that may cause vascular disease in young people.\n\nEligibility:\n\nPeople aged 12 to 25 years who (1) have type 2 diabetes; (2) are overweight but not diabetic; (3) or are lean and healthy. Biological parents are also needed.\n\nDesign:\n\nYoung participants will visit the NIH clinic once a year for up to 25 years. Each visit will take 4 days. Before each visit, participants will wear devices to track their sleep, activity, and blood sugar levels for 7 to 10 days.\n\nAt each visit, participants will have tests including:\n\nSamples: They will provide blood, urine, and stool samples.\n\nHeart: They will ride a stationary bike for 6 minutes with stickers applied to their chest.\n\nScans: They will lie on a bed that slides into a tube; the machine will take pictures of the inside of their body.\n\nEnergy: They will wear a hood over their head to measure the air they breathe.\n\nSocial stress: They will give a speech for 10 minutes to show their body s response to stress.\n\nGlucose: They will drink a sweet drink to see how their blood sugar changes.\n\nBiological parents will have 1 study visit. They will have blood tests. They will fill in questionnaires about their lifestyle and stress.\n\n...",[29,27],[328,67,29,329,330],"Cardiovascular Disease","Youth Onset Type 2 Diabetes","Lean",{"date":301,"type":36},{"date":333,"type":36},"2025-03-12",{"date":335,"type":23},"2033-10-31",{"name":104,"class":105},{"id":338,"slug":4,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":17,"sex":18,"minAge":20,"maxAge":88,"enrollmentInfo":339,"targetDuration":4,"studyType":57,"phases":340,"briefSummary":93,"conditions":341,"keywords":342,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":345,"leadSponsor":346,"locationsCount":44},"100494101",{"count":90,"type":23},[92],[28,29],[29,96,28,97],{"date":301,"type":36},{"date":303,"type":23},{"date":102,"type":23},{"name":104,"class":105},{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":357,"conditions":358,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":360,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":367},"100427857","periodontal-assessment-of-a-bariatric-care-population-100427857","NCT04851470","Periodontal Assessment of a Bariatric Care Population","Periodontal Assessment of a Bariatric Care Population, Clinical, Genetic and Microbiological Characteristics. A Cross-sectional Study.","Bariatric","Inclusion Criteria:\n\nEach subject must meet all of the following inclusion criteria to be enrolled in the study:\n\n1. Subject must be over 18 years of age.\n2. Subject must have a BMI of higher or equal to 30 kg\u002F m2\n3. Subject must have voluntarily given written informed consent.\n\nExclusion Criteria:\n\nSubjects meeting any of the following exclusion criteria are not to be enrolled in the study:\n\n1. Subject is currently involved in other research involving the use of antibiotics or novel or unknown medications.\n2. Self-reported pregnancy.\n3. Subject is on chronic treatment (i.e., two weeks or more) with specific medications known to affect periodontal status (phenytoin or cyclosporine) within one month of baseline visit.\n4. Subject knowingly has HIV or Viral Hepatitis.\n5. Patients are completely edentulous.\n6. Subject with uncontrolled systemic illnesses.\n7. Subject is not capable to give informed consent.\n8. Subjects on chronic antibiotic therapy (ie two weeks or more in the previous month).",{"count":356,"type":23},394,"Our primary aim is to investigate the prevalence and severity of Periodonotal Disease (PD) in a population of obese patients.\n\nOur secondary objectives are to:\n\nInvestigate inflammatory biomarkers that have been associated with PD in the saliva of obese patients.\n\nInvestigate the association of FTO gene (Obesity) polymorphisms with the prevalence of PD in this population.\n\nInvestigate and describe the subgingival microbial flora in obese patients with PD from subgingival dental plaque samples as well as the salivary samples.",[359,29],"Bariatric Surgery Candidate",{"date":301,"type":36},{"date":362,"type":36},"2014-01-31",{"date":364,"type":23},"2027-12-31",{"name":366,"class":43},"Queen Mary University of London",4,{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":17,"sex":18,"minAge":112,"maxAge":375,"enrollmentInfo":376,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":378,"conditions":379,"keywords":382,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":44},"100239105","children-s-growth-and-behavior-study-100239105","NCT02390765","Children s Growth and Behavior Study","Children's Growth and Behavior Study","* Eligibility Criteria for Parents\u002FGuardians of Child Participants:\n\nINCLUSION CRITERIA:\n\nParents\u002FGuardians will qualify if they meet the following criteria.\n\n1. Age \\>=18 years\n2. Have a child enrolled in this protocol (15-CH-0096).\n\nEXCLUSION CRITERIA:\n\nParents\u002FGuardians will be excluded for the following reasons:\n\n1. If their child is not eligible to participate in the study (see below)\n2. If they are believed by the medical study team to have a medical or psychiatric problem that will not allow them to complete study procedures safely (these will be determined on a case-by-case basis)\n\n   Eligibility Criteria for Child Participants:\n\n   INCLUSION CRITERIA:\n\n   Volunteers will qualify if they meet the following criteria.\n   * Age 8-17 years (NB: children may continue to participate as adults during follow-up).\n   * Weight, height and BMI \\>= 5th percentile for age and sex according to Centers for Disease Control and Prevention 2000 US standards.\n   * Cognitively capable of completing study procedures (FSIQ \\>= 70).\n   * Good general health based on a normal history and physical examination (with the exception of overweight and minor, well-controlled illnesses).\n\n   EXCLUSION CRITERIA:\n\n   Individuals will be excluded (and provided treatment referrals as needed) for the following reasons:\n   * History of major cardiovascular disease or any other serious obesity-related complication as assessed during history and physical exam. Individuals with untreated or major illnesses relating to the endocrine and\u002For cardiovascular systems are excluded because these illnesses will likely influence outcomes. Such obesity-related comorbidities include hypertension (defined by age- sex- and height- specific standards; and fasting hyperglycemia consistent with diabetes (fasting glucose \\> 126 mg\u002FdL).\n   * Presence of other major illnesses: renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing syndrome, untreated hyper- or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication). Non-serious medical illnesses, such as seasonal allergies, will be reviewed on a case-by-case basis.\n   * Regular use of any medication known to affect body weight or eating behavior (e.g., many medications prescribed for attention deficit hyperactivity disorder, or ADHD). Medication use for non-serious conditions (e.g., acne) will be considered on a case-by-case basis.\n   * Current pregnancy or a history of pregnancy. A negative pregnancy test before starting the study will be required for postmenarcheal girls.\n   * Current and regular use of tobacco products and\u002For alcohol.\n   * A significant reduction in weight during the past three months, for any reason, exceeding 5% of body weight.\n   * A history of significant or recent brain injury that may considerably influence performance on neurocognitive measures (i.e., any history of loss of consciousness \\>=30 minutes associated with a head injury, any history of memory loss or hospitalization associated with a head injury, or \\>=2 concussions within last year).\n   * Presence of any significant, full-threshold psychiatric disorder based on DSM criteria such as schizophrenia, bipolar disorder, alcohol or substance abuse, anorexia or bulimia nervosa, or any disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study. These individuals will not be permitted to enroll in the current study and will be referred for treatment. Individuals who present with other psychiatric disorders, including sub-threshold psychiatric disorders, will be permitted to enroll in the study. Sub-threshold psychiatric disorders include symptoms that do not meet diagnostic threshold based on the DSM criteria for mental disorders, but which are nevertheless significantly impairing or distressing. If, based on the opinion of the investigators, a participant requires treatment for his\u002Fher psychiatric symptoms, the individual will be referred for treatment. Participants who develop any psychiatric disorder or significant psychiatric symptoms at any follow-up assessment during the study will not be excluded, but will be provided with treatment referrals.\n   * Any other condition in the child or parents\u002Fguardians that, in the opinion of the investigators, would impede compliance or possibly hinder completion of the study (e.g., significant Learning Disorder).\n\n   Additional exclusions for (optional) stool sample collection include:\n\n   Stool Sample only:\n   * Diagnosis or history of inflammatory bowel disease, including ulcerative colitis or Crohn's disease, celiac sprue, irritable bowel syndrome, or other inflammatory disorders of the intestine.\n   * Diarrhea within 1 week prior to sampling.\n   * Antibiotic use within 4 weeks prior to sampling.\n\n   In addition, Experiments 1 and 2 have specific additional exclusions:\n\n   Experiment 1 only:\n   * Regular use of medications that could influence autonomic or endocrine functioning, including alpha and beta blockers, oral contraceptives, or prescription pain medication.\n   * Scoring as \"highly active\" on the International Physical Activity Questionnaire (due to decreased cortisol reactivity).\n\n   Experiment 2 only:\n   * Participants will be excluded if MRI and MEG is contraindicated (metal in\u002Fon body, braces, presence of non-organic \\[e.g., cochlear\\] implants or cerebral clips, permanent tattooed makeup or general tattoos that are recent and\u002For in a dangerous location on the body or made with colors whose content in iron cannot be definitely ruled out.\n   * Youth will be excluded if they are left-handed.\n\n   All participants will receive a written explanation of the purposes, procedures, and potential hazards of the study. Communication of this information and of the participant's assent as well as the consent of the parent or guardian will be documented in the medical record and copies of all signed documents given to each family. All participants will be informed of their right to withdraw from the study.","100 Years",{"count":377,"type":23},1500,"Background:\n\n\\- Studies show that many factors affect children's eating behavior and health. These include sleep, mood, thinking skills, and genetics. Studying children over time may identify children at higher risk for eating-related health concerns.\n\nObjective:\n\n\\- To understand how genes and environment influence eating behavior and health over time.\n\nEligibility:\n\n\\- Children ages 8-17 in good general health.\n\nDesign:\n\n* Screening visit 1: Medical history, physical exam, body measurements, and questions.\n* 14 days: Participants will wear a wrist monitor and answer smartphone prompts about eating and mood. They may give a stool sample.\n* Screening visit 2:\n* Body measurements.\n* Saliva, urine, and blood samples.\n* Heart tests.\n* Meals provided (after fasting overnight).\n* Questionnaires and interview.\n* Behavior, thinking, and exercise tests.\n* X-ray of left wrist and full body.\\\u003CTAB\\>\n* Some parents may have medical history, physical exam, and questions at screening visits. They may answer questions at the yearly visits.\n* Participants will have up to 6 yearly visits. They will give a urine sample and body measurements, and repeat the X-rays. They will have questions and behavior and thinking tasks. They may give stool samples. Visits will range from 3 to 8 hours.\n* Participants may choose to participate in other studies:\n* Stress and Hormones, 1 visit: While resting, participants will give saliva samples and have their heart monitored. Then they will do math. They will repeat the resting part, then do a computer task.\n* Brain Imaging, 2 visits: Twice, participants will perform tasks with a magnetic cone on their head then answer questions. Once, they will have an MRI, lying still in a scanner with a coil on their head. Before the first visit, participants will collect at-home saliva samples once a day for three days. During both visits, participants will perform tasks and answer questions that gauge their thinking skills and mood.\n* Experiment 3 (sleep\u002Ffatigue): Participants will complete 2 additional visits. During these visits, participants will complete a task on the computer for 2 hours, or watch a movie for two hours. After completion of the task\u002Fmovie, they will answer questions and be provided with food.\n\nParticipants will be compensated for the time and inconvenience involved with completing study procedures.\n\n...",[29,380,381],"Eating Behaviors","Healthy Volunteers",[383,384,385,29,386,387],"Stress Response","Binge Eating","Eating Behavior","Disordered Eating","Natural History",{"date":301,"type":36},{"date":390,"type":36},"2015-04-21",{"date":392,"type":23},"2030-12-31",{"name":394,"class":105},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)",{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":230,"minAge":402,"maxAge":88,"enrollmentInfo":403,"targetDuration":4,"studyType":57,"phases":405,"briefSummary":407,"conditions":408,"keywords":409,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":422},"100633209","phase-1-effect-of-maridebart-cafraglutide-on-how-oral-contraceptives-are-absorbed-and-processed-in-the-body-in-postmenopausal-female-participants-living-with-overweight-or-obesity-100633209","NCT07523711","Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Body in Postmenopausal Female Participants Living With Overweight or Obesity","A Phase 1, Open-label Study to Assess the Effect of Maridebart Cafraglutide (AMG 133) on the Pharmacokinetics of Oral Contraceptives in Postmenopausal Female Participants Living With Overweight or Obesity","Inclusion Criteria\n\n1. Participants must be postmenopausal females 45 to 65 years of age. Postmenopausal status must be confirmed based on the protocol-defined criteria.\n2. Body mass index must be ≥ 25.0 and ≤ 38.0 kg\u002Fm\\^2.\n3. Body weight must be stable, with less than 5 kg self-reported change in the 3 months before screening.\n4. Participants must not have changed their diet or started a nutritional lifestyle modification program within 3 months before screening.\n5. Other inclusion criteria may apply.\n\nExclusion Criteria\n\n1. History or evidence of any clinically significant medical condition, abnormal physical exam, ECG, vital sign, or laboratory finding that could increase risk or interfere with study participation.\n2. History of diabetes, active diabetes, or hemoglobin A1c 6.5% or higher.\n3. Endocrine disorders that can cause obesity, such as Cushing's syndrome.\n4. History of acute or chronic pancreatitis within 1 year before check-in, pancreatic enzyme elevations greater than 2 times the upper limit of normal, or fasting triglycerides greater than 300 mg\u002FdL.\n5. Bleeding or clotting disorders, abnormal coagulation tests, or a history of venous or arterial blood clots or conditions that increase clot risk.\n6. LDL cholesterol greater than 159 mg\u002FdL.\n7. Migraine with aura, normal pressure hydrocephalus, or ischemic optic neuropathy.\n8. Malignancy within the past 5 years, except nonmelanoma skin cancer.\n9. Unexplained postmenopausal vaginal bleeding, untreated endometrial disease, or other gynecologic conditions that could worsen with estrogen\u002Fprogestin therapy.\n10. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, or uncontrolled thyroid disease.\n11. Gastroparesis, inability to swallow oral medication, clinically important gastrointestinal disease, malabsorption, uncontrolled inflammatory bowel disease, certain gastrointestinal surgeries, or recent bariatric surgery.\n12. Clinically significant cardiovascular disease, clinically significant arrhythmia, long QT syndrome, QTcF greater than 470 msec, second- or third-degree atrioventricular block, or clinically important abnormal pulse rate or systolic blood pressure \\> 150 mmHg or \\\u003C 90 mmHg, diastolic blood pressure \\> 95 mmHg or \\\u003C 50 mmHg.\n13. Allergy, hypersensitivity, intolerance, or contraindication to maridebart cafraglutide, ethinyl estradiol, or orgestimate.\n14. Reduced kidney function with estimated glomerular filtration rate 60 mL\u002Fmin\u002F1.73 m\\^2 or lower, ALT or AST greater than 2 times the upper limit of normal, or a history of acute or chronic liver disease, hepatic adenoma, or hepatic carcinoma.\n15. Hemoglobin or hematocrit below the lower limit of normal.\n16. Positive HIV test, or positive hepatitis B surface antigen or hepatitis C antibody at screening.\n17. Lifetime history of suicide attempt, non-suicidal self-injury within 5 years, or unstable major depressive disorder or other severe psychiatric disorder within 2 years.\n18. Positive pregnancy test at screening or check-in.\n19. Recent use of medications that could affect study participation, including most prescription or over-the-counter medications, systemic hormone replacement therapy, certain contraceptive hormones, CYP enzyme inducers or inhibitors, GLP-1 receptor or GIP receptor agents, and nonpermitted herbal products, vitamins, or supplements.\n20. Recent participation in another investigational study, prior participation in this study, or prior exposure to maridebart cafraglutide.\n21. Tobacco or nicotine use within 3 months before check-in, positive cotinine test, history of alcoholism or drug abuse, positive alcohol or illicit drug testing, recent illicit drug use, or unwillingness to avoid illicit drugs or cannabinoids during the study.\n22. Recent blood, plasma, or platelet donation.\n23. Other exclusion criteria may apply.","45 Years",{"count":404,"type":23},45,[406],"PHASE1","The primary objective of the trial is to evaluate the effect of maridebart cafraglutide on the pharmacokinetics (PK) of a combined oral contraceptive (COC) in postmenopausal female participants living with overweight or obesity.",[67,29],[410,411,412,413],"Maridebart Cafraglutide","AMG 133","Norgestimate","Ethinyl Estradiol","2026-06-30",{"date":299,"type":36},{"date":417,"type":36},"2026-04-09",{"date":419,"type":23},"2026-11-18",{"name":421,"class":275},"Amgen",3,{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":431,"enrollmentInfo":432,"targetDuration":4,"studyType":57,"phases":434,"briefSummary":435,"conditions":436,"keywords":439,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":442,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":448},"100595823","phase-3-maridebart-cafraglutide-in-heart-failure-with-preserved-or-mildly-reduced-ejection-fraction-and-obesity-100595823","NCT07037459","Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity","A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)","MARITIME-HF","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of informed consent.\n* BMI ≥ 30.0 kg\u002Fm\\^2 at randomization.\n* HF diagnosed for at least 30 days with New York Heart Association (NYHA) Class II-IV at the time of informed consent.\n* Managed with HF standard of care therapies.\n* Left ventricular ejection fraction (LVEF) of \\> 40% within 12 months before randomization.\n\nExclusion Criteria:\n\n* History of any of the following within 60 days prior to or during screening: Type I (spontaneous) MI, valvular replacement or repair, coronary revascularization, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke.\n* HF due to: hypertrophic cardiomyopathy, infiltrative cardiomyopathy, active or chronic myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy\u002Fdysplasia, uncorrected primary valvular heart disease, clinically significant congenital heart disease.\n* Hospitalized with acute decompensated HF at the time of or during the screening period.\n* Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or history of gestational diabetes.\n* For participants with a prior diagnosis of T2DM (including those diagnosed during screening):\n\n  1. HbA1c \\> 10.0% (86 mmol\u002Fmol) at screening\n  2. Uncontrolled diabetes requiring immediate therapy\n  3. History of diabetic ketoacidosis or hyperosmolar state\u002Fcoma within 12 months before randomization\n  4. One or more episodes of severe hypoglycemia within 6 months before randomization and\u002For history of hypoglycemia unawareness\n  5. History or presence of either proliferative diabetic retinopathy, or diabetic maculopathy, or severe non-proliferative diabetic retinopathy; or currently receiving or planning to receive treatment for diabetic retinopathy and\u002For macular edema.\n* SBP ≥ 180 mmHg during the screening period, or on three or more blood pressure-lowering drugs with a SBP \\> 160 mmHg during the screening period (including day 1 prior to randomization).\n* History of chronic pancreatitis or acute pancreatitis in the 180 days before screening or during the screening period.\n* Any personal lifetime history of, or family history(first-degree relative\\[s\\]) of medullary thyroid carcinoma or MEN-2.\n* eGFR \\\u003C 20 mL\u002Fmin\u002F1.73 m\\^2 (CKD-EPI creatinine (Cr)-cystatin C equation) or receiving dialysis at screening.\n* Calcitonin ≥ 50 ng\u002FL (pg\u002FmL) at screening.\n* Acute or chronic hepatitis.\n* Any of the following psychiatric history:\n\n  1. History of unstable major depressive disorder or other severe psychiatric disorder within 2 years prior to screening or during the screening period\n  2. Lifetime history of suicide attempt\n  3. History of non-suicidal self-injury within 5 years prior to screening or during the screening period.\n* History of any other condition that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the trial.\n* Use of any glucagon-like peptide 1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) agonists or antagonists, or amylin analogs within 90 days prior to or during the screening period or planned use during the conduct of the trial.","99 Years",{"count":433,"type":23},5056,[264],"This trial will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and improvement in HF symptoms in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) who are obese. This is a phase 3, global, multicenter, 2-part trial with a double-blind period and an open-label extension (OLE). The trial is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.",[437,438,29],"Heart Failure With Preserved Ejection Fraction","Heart Failure With Mildly Reduced Ejection Fraction",[440,29,410,411,441],"Heart Failure","MariTide",{"date":301,"type":36},{"date":444,"type":36},"2025-06-25",{"date":446,"type":23},"2030-09-29",{"name":421,"class":275},628,{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":17,"sex":18,"minAge":456,"maxAge":375,"enrollmentInfo":457,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":459,"conditions":460,"keywords":465,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":472,"startDateStruct":473,"completionDateStruct":4,"leadSponsor":475,"locationsCount":422},"100143838","characterization-of-patients-with-uncommon-presentations-andor-uncommon-diseases-associated-with-the-cardiovascular-system-100143838","NCT01143454","Characterization of Patients With Uncommon Presentations and\u002For Uncommon Diseases Associated With the Cardiovascular System","Cardiovascular Disease Discovery Protocol","* INCLUSION CRITERIA:\n\nEligible subjects may include anyone over 1 year of age who is affected with diseases\u002Fdisorders (index cases), or who is a relative of a person who is affected with diseases\u002Fdisorders. Relatives may include genetic carriers and non-carriers.\n\n* Healthy adult volunteers must be 18 years of age or older, and must agree to have blood or tissue samples studied, and potentially stored for future research.\n* Index cases enrolled in this protocol will have been referred with a known or suspected pathology that may be associated with cardiovascular dysfunction or risk with a suspected atypical presentation, heritable disorder, or genetic predisposition. The investigator with expertise in the presentation of the subject, along with consulting specialists, will review the medical history and may review any medical records that are available of prospective subjects and offer admission based upon the potential to help the individual, to learn from the subject, or to initiate clinical or basic research suggested by the subject s workup.\n\nEXCLUSION CRITERIA:\n\n* Persons of less than 1 year of age or greater than 100 years of age\n* Healthy volunteers unable to give informed consent or who decline to have blood and\u002For tissue studies, or who do not consent to have samples stored for future research may be excluded from this study.\n* Pregnant women\n* Persons who are not fluent in the English language will be excluded from Patient Reported Outcome Questionnaires. Such persons would be unable to properly complete questionnaires that are only valid in the English language.","1 Year",{"count":458,"type":23},5000,"Background:\n\n\\- Researchers are interested in studying individuals who have known or suspected metabolic, inflammatory or genetic diseases that may put them at a high risk for heart diseases or diseases of their blood vessels. Depending on the condition being studied, both affected and nonaffected individuals may be asked to provide blood and other samples and may undergo tests to evaluate the heart, blood vessels and lung function. The testing is tailored to the individual and\u002For condition being studied. Nonaffected individuals may include relatives of affected individuals and healthy nonrelated volunteers.\n\nObjectives:\n\n\\- To study individuals who have or are at risk for cardiovascular diseases, and in some cases their unaffected relatives and healthy volunteers.\n\nEligibility:\n\n\\- Individuals between 1 and 100 years of age. Participants may be healthy volunteers, individuals with cardiovascular diseases, or unaffected relatives of individuals with cardiovascular diseases.\n\nDesign:\n\n* Participants will have some or all of the following tests, as directed by the study researchers:\n* Photography of the face and full body\n* Body measurements\n* Radiography, including chest or limb x-rays\n* Metabolic stress testing to study heart and muscle function\n* Echocardiography to study heart function\n* Magnetic resonance imaging (MRI) studies, including cardiovascular MRI, angiography, and contrast MRI, to study heart function and performance\n* Computed tomography (CT) angiogram to obtain images of the heart and lungs\n* Positron emission tomography (PET) imaging to study possible fat infiltration of the heart\n* Six-minute walk test to study heart, lung, and muscle function and performance\n* Vascular ultrasound to study blood vessel walls\n* Blood, tissue, and other specimens will be collected for research and testing, and will be taken either as part of the clinical study or during surgical procedures.\n* Follow-up studies may be performed under separate research protocols.",[30,29,461,462,463,464],"Li-Fraumeni Syndrome","Cardiomyopathy","Atherosclerosis","Inflammatory Disease",[466,467,468,469,387,470,471],"Cardiac Disease","iPS Cells","Cardiac Risk Factors","Cardiac Disease Discovery","Heart Disease","Heart Disease Risk",{"date":299,"type":36},{"date":474,"type":36},"2010-07-21",{"name":476,"class":105},"National Heart, Lung, and Blood Institute (NHLBI)",{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":17,"sex":18,"minAge":484,"maxAge":431,"enrollmentInfo":485,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":486,"conditions":487,"keywords":490,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":44},"100322739","early-tracking-of-childhood-health-determinants-etched-study-100322739","NCT03481829","Early Tracking of Childhood Health Determinants (ETCHED) Study","Early Tracking of Childhood Health Determinants Study","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Pregnant women aged 18 years or older (pregnancy confirmed by urine or serum pregnancy test, or ultrasound examination)\n2. American Indian or Hispanic by self-report\n3. Agree to continue with research study participation (both mother and their offspring), for at least 3 years after delivery.\n\nIn case where a pregnant mother is carrying multiple fetuses (multiple pregnancy), she will be eligible to participate in this study and all her live newborns, as a result of that pregnancy, will be eligible for participation in this study. Mothers will also be eligible to participate with any consecutive pregnancies.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Women who are incarcerated or are unable to consent.\n2. Women whose fetus is not viable or are not planning to continue the pregnancy.","1 Day",{"count":377,"type":23},"Background:\n\nChildren s weight has increased sharply in recent years. This may put them at higher risk for health problems. High blood glucose in a pregnant mother and too much weight gain during pregnancy also may have long-term effects on the child s health. Children who become overweight or obese during childhood tend to remain so as adults. Researchers want to study many risk factors during and after pregnancy, and how these affect a child s development. They will also follow the mother s health and well-being after pregnancy.\n\nObjectives:\n\nTo learn how a pregnant mother s environment, lifestyle, and health conditions may affect her child s growth and development from birth until adulthood.\n\nEligibility:\n\nAmerican Indian\u002FAlaska Native (AI\u002FAN) or Hispanic adult pregnant women and their offspring.\n\nDesign:\n\nMothers will have 3 visits during pregnancy.\n\nIn the child s first year, mothers will have 2 visits and their child will have 4.\n\nChildren will have 2 visits in their second year and 1 each year until they turn 18.\n\nMothers will have a visit 2 years after birth and 4-5 years later.\n\nBoth the mother and child s medical records will be reviewed. They will have physical exams and give blood and stool samples.\n\nMothers may give cord blood and placenta samples. They will give breastmilk and urine samples. They will fill out questionnaires.\n\nThey will have an ultrasound. They may get an activity monitor.\n\nMother and child will be followed until the child s 18th birthday.\n\n...",[488,29,489],"Diabetes Mellitus","Fatty Liver",[491,29,238,117,492,493,387],"American Indians, Hispanics","Children","Hispanics","2026-06-27",{"date":414,"type":36},{"date":497,"type":36},"2022-04-14",{"date":499,"type":23},"2041-12-31",{"name":104,"class":105},{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":17,"sex":18,"minAge":20,"maxAge":508,"enrollmentInfo":509,"targetDuration":4,"studyType":57,"phases":511,"briefSummary":512,"conditions":513,"keywords":517,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":521,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":44},"100113251","phase-2-effects-of-brain-stimulation-on-food-intake-and-behavioral-weight-loss-treatment-100113251","NCT00739362","Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment","The Effects of Transcranial Direct Current Stimulation (TDCS) on Food Intake and Weight Loss","* INCLUSION CRITERIA:\n* BMI \\>= 25 kg\u002Fm\\^2\n* Age 18-60 years. Women who are post-menopausal will be excluded from the study due to changes in their metabolism that could affect weight loss. We will set the cutoff at age 60 so that the age difference between the men and women is not too great for analysis purposes. Minors under the age of 18 will be excluded because the time requirements of the study are such that they would interfere with school schedules.\n* Right-handedness (because the treatment will be given to the left dorsolateral prefrontal cortex and the evidence accumulated in this region was only in right-handed individuals).\n* Weight stable (+\u002F- 5 percent) for last 3 months as determined by volunteer report.\n\nEXCLUSION CRITERIA:\n\n* Weight \\> 300 lbs (136 kg), as this is the general size limit of the fMRI machine. Participants \\>300 pounds may be included if their body habitus will allow them to fit within the diameter of the MRI machine. This will be determined on a case-by-case basis after consultation with staff at Banner Health Neuroimaging Center.\n* Use of medication affecting metabolism and appetite in the last three months\n* Current pregnancy, pregnancy within the past 6 months or currently lactating\n* History or clinical manifestations of acute or chronic disorders or conditions that may affect appetite or energy expenditure (such as, but not limited to type 1 or type 2 diabetes, Cushing s disease, thyroid disorders, coccidiomycoses)\n* Gastrointestinal disease, including inflammatory bowel diseases (e.g. Chron s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active) which may alter metabolism\n* Current, unstable medical conditions such as hepatitis, renal insufficiency, cancer requiring treatment in the last 5 years, or central nervous system disorders etc. as assessed by history and physical exam\n* Evidence of alcohol abuse as defined by \\>= 8 point score on the Alcohol consumption screening AUDIT questionnaire in adults\n* Evidence of drug use such as amphetamines, cocaine, heroin, or marijuana\n* Current use of tobacco products that exceed \"Very Low Dependence\" on the Fagerstr(SqrRoot)(Delta)m Test for Nicotine Dependence Tool (score greater than 2)\n* Postmenopausal women or symptoms of perimenopause (e.g. hot flashes, onset of irregular periods following age 40, elevation of FSH \\>20 IU following age 40 years)\n* Any conditions contraindicated for MRI (e.g., pacemaker, metal in the cranial cavity, significant claustrophobia, holes in the skull made by trauma or surgery)\n* Any condition not specifically mentioned above that, in the opinion of the investigator, may interfere with the study or prove unsafe for participation.","60 Years",{"count":510,"type":23},148,[92],"This study will determine whether electrical stimulation of an area of the brain called the dorsolateral prefrontal cortex, which is important in determining the feeling of fullness after eating, affects how much food a person eats and weight loss over 4 weeks. It will also compare weight changes in people who attend weight loss counseling sessions and those who do not over this period of time.\n\nObese, non-diabetic people between 18 and 60 years of age who are in good health and who live in the Phoenix, AZ, metropolitan area are eligible for this study. Candidates must have a body mass index of 35 kg\u002Fm(2) or more and weigh less than 350 pounds.\n\nParticipants are admitted to the NIH inpatient unit in Phoenix for the first 9 days of the study for tests, which include meal tests to determine eating behaviors and caloric intake, blood and urine tests, glucose tolerance test, weight measurement, psychological assessments and DEXA scan to measure body fat. For 3 of the days, they will be asked to eat all of their food from automated vending machines. Some subjects receive transcranial direct current stimulation (TDCS). For this procedure, electrodes that conduct electricity are placed on the head and arm and the current is turned on for 40 minutes. Some tingling may be felt under the electrodes. Other subjects receive sham TDCS, with the current turned on only very briefly.\n\nAfter the evaluations, subjects are discharged home from the NIH unit and instructed to eat 25 percent fewer calories than they consumed while on a weight maintenance diet the first 3 days of their inpatient stay. They maintain the lower calorie diet at home for 4 weeks. During this period they come to the NIH unit 3 days a week to receive either real or sham TDCS.\n\n...",[514,29,515,516],"Electric Stimulation Therapy","Weight Loss","Eating",[518,29,519,515,520],"Behavioral Weight Loss Treatment","Appetite Control","Transcranial Direct Current Stimulation (TDCS)",{"date":414,"type":36},{"date":523,"type":36},"2009-01-19",{"date":525,"type":23},"2027-01-31",{"name":104,"class":105},{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":17,"sex":534,"minAge":20,"maxAge":88,"enrollmentInfo":535,"targetDuration":4,"studyType":57,"phases":537,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":44},"100645244","phase-1-study-of-single-and-multiple-oral-doses-of-scb0020160-in-healthy-adult-male-subjects-100645244","NCT07682337","Study of Single and Multiple Oral Doses of SCB0020160 in Healthy Adult Male Subjects","A First-in-Human, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Food Effect of SCB0020160 After Oral Administration in Healthy Adult Male Subjects","Inclusion Criteria:\n\n* Healthy adult male volunteers in the opinion of the principal investigator or delegate, aged 18 to 65 years at screening\n* Body weight more Than or equals to 45.0 kilograms per square meter at screening, with a body mass index (BMI) of more than or equals to18.0-kilogram Meter square and less than or equals to 32.0 Kilograms per meter square\n\n  * Body Mass Index (BMI, kilograms per square meter.) = Weight (kilogram)\u002F\\[Height square meter\\]\n* Eligible to participate in the study based on the results of physical examination, clinical laboratory tests, history taking, and other examinations performed at screening, as determined by the principal investigator or delegate\n* Has voluntarily decided to participate and provided written or electronic consent to comply with the precautions after receiving a full explanation of the study and fully understanding it\n\nExclusion Criteria:\n\n* Has a history of or currently has any disease, including clinically significant hepatobiliary (severe liver impairment, viral hepatitis, etc.), renal (severe renal impairment, etc.), neurological, immunological, respiratory, digestive, endocrine, hematologic and oncologic, cardiovascular (Torsades de pointes, etc.), urological, psychiatric (mood disorders, obsessive compulsive disorder, etc.), and sexual function disorders\n* Has a history of or currently has a gastrointestinal disease (Crohn's disease, ulcerative colitis, etc.) that may affect the safety and pharmacokinetic evaluation of the investigational product, or has a history of gastrointestinal surgery (except for simple appendectomy or hernia surgery)\n* Has a history of hypersensitivity to the active pharmaceutical ingredient and components of the investigational product, drugs in the same class as the active pharmaceutical ingredient, or other drugs (aspirin, antibiotics, etc.)\n* Has genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption\n* Has any of the following results in vital signs measured in a sitting position after resting for at least 5 minutes at screening\n* Systolic blood pressure more than 80 millimeters of mercury or greater than or equal to140 mmHg\n* Diastolic blood pressure less than 45 millimeters of mercury or greater than or equal to140 mmHg 90 millimeters of mercury\n* Pulse rate less than 45 beats\u002Fmin or \\> 105 beats\u002Fmin\n* Has any of the following results in the 12-lead electrocardiogram measured in a semi-supine position after resting for at least 5 minutes at screening, or has clinically significant rhythm findings\n* QTcF less than 450 msec\n* Has any of the following results in the screening clinical laboratory tests\n* Estimated Glomerular Filtration Rate (eGFR) (CKD-EPI equation) \\\u003C 90 mL\u002Fmin\u002F1.73 m²\n* Fasting serum glucose more than 5.4 millimoles per liter. or less than 3.0 millimoles per liter.\n* AST or ALT 1.5 X the upper limit of normal (ULN)\n* Total cholesterol less than 5.5 millimoles per liter\n* Triglyceride less than 2.0 millimoles per liter.\n* Drinks alcohol persistently (less than 21 units\u002Fweek, 1 unit = 10 gram = 12.5 milli liter of pure alcohol) or is unable to refrain from alcohol consumption from 3 days prior to the expected first dose of the investigational product until the end of the study\n* Tested positive for the breath alcohol test at screening or at check-in on D-1 10) Smokers (However, those who quit smoking 3 months prior to the expected first dose of the investigational product may be eligible as subjects)\n* Tested positive for the urine cotinine test at screening or at check-in on D-1, even if they do not smoke\n* Has taken any prescribed drugs or herbal medicines within 2 weeks prior to the expected first dose, or has taken any over-the-counter (OTC) drugs, health functional foods including liver supplements, or vitamins within 1 week (However, they may participate in the study if the investigator deems their other conditions appropriate), or is expected to take any of the said agents\n* Has taken drugs that induce drug-metabolizing enzymes, such as barbiturates, or drugs that inhibit drug metabolism, such as clarithromycin, within 1 month prior to the expected first dose\n* Has a history of alcohol or drug abuse, or has shown a positive result for abused drugs in a urine drug test at screening or at check-in on D-1\n* Has participated in another study (including bioequivalence studies) and received an investigational product within 3 months prior to the first dose\n* Has donated whole blood within 2 months, donated blood components within 1 month, or received a blood transfusion within 1 month prior to the expected first dose\n* Has persistently consumed excessive amounts of caffeine (\\> 5 units\u002Fday, 1 unit = 80 mg of caffeine), or is unable to refrain from consuming caffeine-containing foods (coffee, tea (black tea, green tea, etc.), carbonated beverages, coffee-flavored milk, health tonics, energy drinks, etc.) from 3 days prior to the expected first dose of the investigational product until the end of the study\n* Has consumed grapefruit, grapefruit juice, or grapefruit-containing foods from 3 days prior to the expected first dose of the investigational product until the end of the study, or is unable to refrain from consuming grapefruit-containing foods during this period\n* Has unusual eating habits (e.g., consuming more than 1L of grapefruit juice per day) or is unable to consume the standard diet provided by the study site during the inpatient period\n* Tested positive for serological tests (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)\n* Subjects who, or whose spouse (or partner) is a woman of childbearing potential, are unable or unwilling to use methods of contraception considered highly effective for the entire period of the study and for at least 90 days after the last dose of the investigational product, and who do not agree to avoid donating sperm\u002Feggs during this period.\n\n\\[Methods of contraception considered highly effective\\]\n\n* Intrauterine devices and intrauterine hormone-releasing systems with a proven contraception failure rate (\\\u003C 1%\u002Fyear) plus the use of a male condom\n* Bilateral tubal occlusion or bilateral tubal ligation plus the use of a male condom\n* Azoospermia is confirmed by sperm test after vasectomy\n* Hormonal contraception (e.g., combined oral contraceptive, progestogen-only oral contraceptive), contraceptive patch, vaginal ring, injection, subdermal contraceptive implant); however, hormonal contraception is limited to cases where it is being used for 28 days or longer prior to the administration of the investigational product and can be continuously used during the study period and up to 90 days after the last dose plus the use of a male condom.\n* Sexual abstinence, if it is the usual and preferred method of contraception.\n* Those judged by the principal investigator or delegate to be ineligible for participation in the study for reasons other than the above-mentioned criteria (non-compliance with instructions, etc.)","MALE",{"count":536,"type":23},74,[406],"This study aims to evaluate the safety, tolerability, pharmacokinetics, and food effect of a new investigational medicine called SCB0020160 in healthy adult men. This is the first time SCB0020160 will be administered to humans.\n\nHealthy adult men aged 18 to 65 years who meet the study eligibility criteria.\n\nStudy details\n\nParticipants will be randomly assigned to receive either SCB0020160 or placebo. The study includes single-dose and multiple-dose treatment periods, as well as an assessment of the effect of food on the absorption of SCB0020160.\n\nParticipants will undergo safety assessments including physical examinations, vital signs, ECGs, blood and urine tests, and monitoring of adverse events. The study will also assess how SCB0020160 is processed by the body.\n\nThere is no direct health benefit expected from participation. The results may help determine safe dose levels and support future clinical development of SCB0020160.",[540,29,541],"Solid Tumor","Idiopathic Pulmonary Fibrosis","2026-06-26",{"date":301,"type":36},{"date":545,"type":23},"2026-06-29",{"date":547,"type":23},"2027-07-01",{"name":549,"class":275},"SCBIO Inc.",{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":17,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":57,"phases":559,"briefSummary":560,"conditions":561,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":563,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":44},"100524940","ketogenic-diet-and-diabetes-demonstration-project-100524940","NCT06115265","Ketogenic Diet and Diabetes Demonstration Project","KDDP","Inclusion Criteria:\n\n* Men and women ≥ 18 years old\n* BMI ≥27 kg\u002Fm2\n* Hemoglobin A1c ≥ 5.7% and\u002For fasting plasma glucose of 100-125 mg\u002FdL\n\nExclusion Criteria:\n\n* Known clinical cardiovascular disease (i.e. prior stroke, myocardial infarction, peripheral artery disease)\n* LDL cholesterol ≥ 190 mg\u002FdL\n* Triglycerides ≥ 500 mg\u002FdL\n* History of type 1 diabetes\n* History of diabetic ketoacidosis\n* Individuals requiring insulin\n* Advanced renal disease\n* Advanced liver disease\n* Terminal cancer\n* Pregnancy",{"count":558,"type":23},40,[190],"KDDP is a prospective, 12-month pilot study comparing the effects of a novel lifestyle program, the Ketogenic Diet and Diabetes Demonstration Project (KDDP) to those of the National Diabetes Prevention Program (NDDP). KDDP is modeled to mimic the delivery platform of NDPP with the exception that participants in KDDP will be placed on a medically-supervised ketogenic diet, and participants in NDPP will be placed on a low fat diet.\n\nThe purpose of this study is to compare the metabolic effects of the KDDP and the NDPP on glycemic control, lipid parameters, blood pressure, heart rate, weight, and coronary artery calcium scores in individuals with either type 2 diabetes or prediabetes.",[27,31,29,562],"Ketogenic Dieting",{"date":414,"type":36},{"date":565,"type":36},"2023-09-05",{"date":567,"type":23},"2026-10-01",{"name":569,"class":43},"University of New Mexico",{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":18,"minAge":577,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":57,"phases":580,"briefSummary":581,"conditions":582,"keywords":584,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":586,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":44},"100525222","time-restricted-eating-window-timing-type-2-diabetes-status-and-sex-on-glycemic-control-100525222","NCT06118931","Time-restricted Eating, Window Timing, Type 2 Diabetes Status and Sex on Glycemic Control","The Impact of Time-restricted Eating, Window Timing, Type 2 Diabetes Status and Sex on Glycemic Control","Inclusion Criteria:\n\n* Aged 40 years or older\n* Body mass index \\\u003C50 kg\u002Fm2\n* Have access to an Apple or Android cellphone with Bluetooth.\n* Have type 2 diabetes or be at risk for type 2 diabetes (defined as self-report of pre-diabetes, a recent (within 12 months) measure of HbA1c between 5.7 and 6.4%, waist circumference (WC) that is BMI specific; for women: BMI \\>= 18.5-24.9, WC \\>= 80cm; BMI \\>= 25-29.9, WC \\>= 90cm; BMI \\>= 30-34.9, WC \\>= 105cm; BMI \\>= 35+, WC \\>= 115cm; for men: BMI \\>= 18.5-24.9, WC \\>= 90cm; BMI \\>= 25-29.9, WC \\>= 100cm; BMI \\>= 30-34.9, WC \\>= 110cm; BMI \\>= 35+, WC \\>= 125cm.\n\nExclusion Criteria:\n\n* Individuals with type 2 diabetes will be excluded if: (1) currently on \\>2 monotherapies for diabetes, (2) have had diabetes therapy medication or dosage changes \\\u003C3 months, (3) self-reported hemoglobin A1c \\>9.0%, (4) taking exogenous insulin, or (5) taking sulfonylureas\n* The following exclusion criteria applies to all potential participants:\n\n  1. History of or referral for bariatric surgery\n  2. Weight loss \\>3% in the last 3 months\n  3. Taking antiobesity (weight loss) medications\n  4. Body weight \\>390lbs\n  5. Diagnosed with severe cognitive disorder that precludes them from giving consent\n  6. Inability or unwillingness to change their eating window to follow those prescribed in the study\n  7. Currently consistently eating during \\\u003C11.5 hour period .\n  8. Physician-diagnosed eating disorder\n  9. Having a pacemaker or receiving dialysis.\n  10. Not having access to a Lifelabs location.","40 Years",{"count":579,"type":23},123,[190],"This study will evaluate the effectiveness of time-restricted eating (TRE), which is a form of intermittent fasting. When performing TRE, individuals consume all of their calories within a specific time window and then only consume water or other no calorie drinks the rest of the day. TRE is performed each day. There is no restriction on the quality or amount of food that people can consume during their eating window (ad libitum eating) with TRE, which can last anywhere from 4 to 12 hours. We are comparing three different 9-hour eating windows to determine whether the start and stop time of the eating window impact blood sugar control in individuals with obesity who also have or are at risk for type 2 diabetes. We also aim to determine if there are differences in the effects of the timing of eating window between males and females.",[141,29,583,121],"Prediabetic State",[585,27,29,146],"Time-restricted eating",{"date":414,"type":36},{"date":588,"type":36},"2025-06-28",{"date":590,"type":23},"2027-06-28",{"name":592,"class":43},"University of Toronto"]