[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetes":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,250,0,25,[9,45,77,111,123,133,155,183,207,233,257,275,301,331,355,382,432,455,483,502,520,557,585,612,630],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053739","evaluation-of-the-clinical-spectrum-of-diabetes-and-obesity-in-youth-and-adults-100053739",false,"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.","ALL","8 Years","65 Years",{"count":20,"type":21},1000,"ESTIMATED","OBSERVATIONAL","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.",[25,26,27],"Obesity","Diabetes","Metabolic Disorders",[29,25,30,31],"Clinical Spectrum of Diabetes","Hyperglycemia","Metabolic Disease","NOT_YET_RECRUITING","2026-07-10",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":21},"2026-07-16",{"date":40,"type":21},"2055-04-30",{"name":42,"class":43},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":66,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":74,"leadSponsor":76,"locationsCount":44},"100054144","phase-2-effects-of-meal-macronutrients-on-postprandial-lipids-100054144","NCT07313787","Effects of Meal Macronutrients on Postprandial Lipids","Prospective Cross-Over Study of the Effects of Meal Macronutrients on Postprandial Lipids","* INCLUSION CRITERIA:\n\nCommon inclusion criteria (all groups):\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Age \\>= 18 years\n2. Average alcohol intake in the past 6 months \\\u003C 3 drinks (approximately 30g) per day (male) or \\\u003C 2 drinks (approximately 20 g) per day (female)\n\nHealthy control specific inclusion criteria:\n\n1. In good general health with no known active medical conditions as evidenced by medical history\n2. Fasting glucose \\\u003C100 mg\u002FdL\n3. HbA1c \\\u003C5.7%\n4. Fasting triglycerides \\\u003C150 mg\u002FdL\n5. ALT and AST within normal limits\n6. BMI \\>=18.5 to \\\u003C25 kg\u002Fm\\^2 (or \\\u003C23 kg\u002Fm\\^2 in participants of Asian descent)\n7. Not taking any medications or supplements that, in the opinion of the investigator, would interfere with interpretation of study data.\n\nMetabolic syndrome specific inclusion criteria\n\n1\\. Obesity defined as either\n\n1. BMI \\>30 kg\u002Fm\\^2 (or \\>=27 kg\u002Fm\\^2 in participants of Asian descent), OR\n2. Elevated waist circumference as defined below:\n\n   * Country\u002FEthnic group - Europid, Sub-Saharan African, Eastern Mediterranean and Middle East (Arab):\n\n     --Sex: Male - Waist circumference: \\>=94cm\n\n     --Sex: Female - Waist circumference: \\>=80cm\n   * Country\u002FEthnic group - South Asian, Chinese, Japanese, Ethnic South and Central American:\n\n     * Sex: Male - Waist circumference: \\>=90cm\n     * Sex: Female - Waist circumference: \\>=80cm\n\n       2\\. Elevated triglycerides defined as EITHER\n\n       2a. Fasting triglycerides \\>= 150 mg\u002FdL at screening, OR\n\n       2b. Specific treatment for hypertriglyceridemia\n\n       3\\. Low HDL cholesterol, defined as EITHER\n\n       3a. HDL \\\u003C40 mg\u002FdL (males) or \\\u003C50 mg\u002FdL (females) at screening, OR\n\n       3b. Specific treatment for low HDL\n\n       4\\. Elevated blood pressure defined as EITHER\n\n       4a. Systolic BP \\>= 130 at screening, OR\n\n       4b. Diastolic BP \\>= 85 mm Hg at screening, OR\n\n       4c. Treatment of previously diagnosed hypertension\n\n       5\\. Elevated glucose defined as EITHER\n\n       5a. HbA1c \\>= 5.7% (at screening), OR\n\n       5b. Fasting serum glucose \\>= 100 mg\u002FdL (at screening), OR\n\n       5c. 2-hour post-load glucose levels \\>= 140 mg\u002FdL (by history), OR\n\n       5d. Prior diagnosis of type 2 diabetes\n\n   Lipodystrophy-specific inclusion criteria:\n   1. Clinical diagnosis of generalized or partial lipodystrophy based on reduction in adipose tissue outside the normal range in some or all adipose depots (including, at aminimum, the gluteofemoral depot).\n   2. Insulin resistance as defined by fasting insulin \\>22.5 or high exogenous insulin requirement (\\> 2 units per kg per day or \\> 200 units total per day) at screening.\n\n   Nephrotic syndrome specific inclusion criteria\n   1. History of biopsy proven non-diabetic glomerular disease (any histology)\n   2. Nephrotic range proteinuria defined by ANY of the following:\n\n   2a. Protein\u002Fcreatinine ratio uPCR \\>= 3.5 g\u002Fg at screening, OR\n\n   2b. 24 hour protein excretion \\>= 3.5 gr\u002F24hr) at screening, OR\n\n   2c. History of nephrotic range proteinuria (as defined above) within the past 5 years but in complete (defined as proteinuria \\\u003C= 0.3 g\u002Fday or partial remission (defined as a 50% or greater decrease in proteinuria compared to baseline and proteinuria \\\u003C 3.5 g\u002Fday) based on 24 hr urine or uPCR at time of screening\n\n   EXCLUSION CRITERIA:\n\n   Common exclusion criteria (all groups):\n\n   An individual who meets any of the following criteria will be excluded from participation in this study:\n   1. Consuming extreme macronutrient diet (e.g., very low-carbohydrate, high fat diets such as ketogenic, paleo or Atkins diets, among others).\n   2. Plans to actively gain or lose weight during the study period (other than changes in water balance as clinically needed in subjects with nephrotic syndrome).\n   3. Change in body weight of \\>5% or \\>3 kg (whichever is larger) in the 3 months prior to screening (by participant report) in participants who do NOT have nephrotic syndrome.\n   4. Body weight \\>450 lbs (upper limit that can be accommodated by DXA scanner).\n   5. Participating in a regular strenuous exercise program (\\> 2h\u002Fweek of vigorous activity) as determined by volunteer report or evidence of vigorous exercising in order to lose weight, change body shape, or to counteract the effects of eating.\n   6. Uncontrolled diabetes, defined as HbA1c \\>9% at screening.\n   7. Lipemia defined as fasting or non-fasting triglycerides of \\>1000 mg\u002FdL at screening.\n   8. Renal dysfunction defined as eGFR \\\u003C50 mL\u002Fmin\u002F1.73 m\\^2 at screening.\n   9. In participants with liver disease, history of decompensated advanced liver disease, defined as direct bilirubin \\> 0.5 g\u002FdL, PT \\> 18 seconds, albumin \\\u003C 3 g\u002FdL, MELD score \\> 12, or history of ascites, encephalopathy, variceal bleeding, spontaneous bacterial\n\n      peritonitis or liver transplant.\n   10. History of hypertriglyceridemia-induced pancreatitis within 3 months prior to screening.\n   11. Positive pregnancy test or breastfeeding at screening.\n   12. Clinically significant abnormalities in thyroid function, blood counts, as assessed by screening labs.\n   13. Acute cardiovascular events within the past 6 months\n   14. Anemia (Hgb \\\u003C10 mg\u002FdL in women or \\\u003C12 mg\u002FdL in men) at screening\n   15. Food allergies or other dietary restrictions that could increase risk associated with test meals or cause the subject to be unwilling to consume test meals (i.e. celiac disease, vegan diets).\n   16. Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other known conditions that could affect intestinal fat absorption.\n   17. Subjects treated with tamoxifen, estrogens, or progestins that have not been stable for \\>4 weeks prior to screening.\n   18. Blood donation in the last 2 weeks or planned blood donation during the study\n   19. Subjects requiring regular transfusions for any reason.\n   20. Subjects with known gastroparesis\n   21. Inability to adhere to Lifestyle Considerations throughout study duration.\n   22. Inability of the subject to understand and the unwillingness to sign a written informed consent document.\n   23. Unwillingness to comply with all study procedures and unavailable for the duration of the study\n   24. Any other condition or medication which, in the opinion of the investigator, increases risk to the subject, prevents the subject from complying with study procedures, prevents the subject from completing the study, or interferes with the interpretation of study results.","18 Years","120 Years",{"count":55,"type":21},100,"INTERVENTIONAL",[58],"PHASE2","Background:\n\nAbnormal fats in the blood can lead to many problems, including heart disease. Researchers want to learn more about how eating meals with different levels of nutrients affects fats in the blood. Specifically, they want to study people with too much body fat, too little body fat, and a kidney problem called nephrotic syndrome.\n\nObjective:\n\nTo learn more about how different types of foods affect fat levels in the blood.\n\nEligibility:\n\nPeople aged 18 years or older with a health condition that affects how their body handles fats. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have 2 overnight stays in the clinic within 6 months. At each visit, after staying overnight, they will eat a breakfast casserole. At 1 visit, breakfast will be a high-fat, low carbohydrate meal. At the other, it will be a high-carbohydrate, low-fat meal.\n\nParticipants will have a tube inserted into a vein in their arm. They will have blood drawn via the tube 12 times in 8 hours: 2 times before they eat the breakfast and 10 times after.\n\nParticipants will have other tests during their stays:\n\n* A resting metabolic test captures the air they exhale and measures how much energy they use at rest.\n* A dual energy X-ray absorptiometry (DXA) scan measures how much fat and muscle they have.\n* A Fibroscan is a special type of ultrasound of the liver.\n* A body surface scan uses lasers to measure the total area of the body.\n* A bioelectric impedance (BIS) exam measures how fast small electric currents move through their body.\n\nParticipants may opt to have a third visit. At this visit, the breakfast will be high in protein....",[61,62,63,64,26,65],"Nephrotic Syndrome","Lipodystrophy","Metabolic Syndrome","Healthy Volunteer","Metabolic Associated Steatotic Liver Disease",[67,68,69,70,71],"postprandial lipids","macronutrient","CARBOHYDRATES","FATS","Proteins",{"date":35,"type":36},{"date":38,"type":21},{"date":75,"type":21},"2031-08-01",{"name":42,"class":43},{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":84,"minAge":52,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":56,"phases":87,"briefSummary":89,"conditions":90,"keywords":96,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"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":86,"type":21},1320,[88],"NA","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.",[91,26,92,93,94,95,25],"Hypertension","Postpartum","Pregnancy","Anxiety","Depression",[97,98,99,100],"Postpartum Care","Primary Care","Care Transitions","Chronic Disease","RECRUITING","2026-07-09",{"date":35,"type":36},{"date":105,"type":36},"2025-05-23",{"date":107,"type":21},"2028-05-23",{"name":109,"class":110},"Massachusetts General Hospital","OTHER",{"id":112,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":114,"keywords":115,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":122,"locationsCount":44},"100622816",{"count":20,"type":21},[25,26,27],[29,25,30,31],"2026-07-01",{"date":118,"type":36},"2026-07-02",{"date":120,"type":21},"2026-07-07",{"date":40,"type":21},{"name":42,"class":43},{"id":124,"slug":4,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":125,"targetDuration":4,"studyType":56,"phases":126,"briefSummary":59,"conditions":127,"keywords":128,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":129,"startDateStruct":130,"completionDateStruct":131,"leadSponsor":132,"locationsCount":44},"100617066",{"count":55,"type":21},[58],[61,62,63,64,26,65],[67,68,69,70,71],{"date":118,"type":36},{"date":120,"type":21},{"date":75,"type":21},{"name":42,"class":43},{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":140,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":44},"100313876","taste-bud-derived-stem-cells-in-humans-100313876","NCT03366168","Taste Bud-Derived Stem Cells in Humans","A Pilot Study of Taste Bud-Derived Stem Cells in Humans","* INCLUSION CRITERIA:\n* Age 18 years and older\n* Healthy (see exclusion criteria below)\n* Are able to understand the study risks and procedures, and consent to participate in the study.\n* Are able to read and speak English.\n\nEXCLUSION CRITERIA:\n\n* Have less than 40 fungiform papillae on the anterior third portion of the tongue as evidenced by tongue photo taken during the screen visit.\n* Does not agree to the use of their tissue samples to produce stem cells.\n* A medical condition that requires the use of chronic anticoagulant medication use such as warfarin, clopidogrel, heparin or antiplatelet agents other than low dose aspirin (81mg).\n* History of increased bleeding due to either a known medical condition or an undiagnosed cause.\n* Active infections or chronic conditions that would prevent access to the biopsy area.\n* Taking non-steroidal anti-inflammatory agents (NSAIDs) such as Motrin (Ibuprofen), Advil (Ibuprofen) or Naprosyn (Naproxen) and the participant is unable to stop taking them 4 days before and 3 days after the final biopsy procedure.\n* Taking more than 81 mg of aspirin a day and the participant is unable to stop taking it for 4 days before and 3 days after the biopsy procedure.\n* Allergic to Lidocaine (Xylocaine) or any other local anesthetic or the participant has had in the past a severe allergic reaction to similar drugs.\n* Have taken steroids, other than ocular within 30 days of their scheduled biopsy procedure.\n* HIV virus infection.\n* Hepatitis B or C.\n* Kidney disease (Creatinine greater than1.5 mg\u002Fdl or calculated creatinine clearance less than 50 cc\u002Fmin).\n* Liver disease (ALT, AST or alkaline phosphatase twice the normal serum concentration).\n* Severe gastrointestinal diseases such as Crohn s disease or ulcerative colitis requiring continuous treatment.\n* History of severe pulmonary disease such as chronic obstructive pulmonary disease (COPD) or asthma requiring continuous medication use.\n* History of using any tobacco products within the past six months.\n* History of severe psychiatric conditions associated with behavioral problems or requiring chronic medical treatment.\n* Currently pregnant or breastfeeding.\n* Current illness that as judged by the study physician substantially increases the risks associated with the tongue biopsy (active infections, allergies, etc.).",true,{"count":5,"type":21},"Background:\n\nStem cells are found in body tissues. They can regenerate into more of the same cells or become other types of cell. Researchers want to use stem cells from taste buds to try to make cells that secrete insulin. Taste buds are found mostly on the tip and sides of the tongue. Researchers also want to study if the number of taste buds and stem cells decrease as people age. They will remove small pieces of tongue tissue (about the size of a pen tip). The taste buds will grow back. It is hoped that studying taste bud stem cells can lead to new diabetes treatments.\n\nObjectives:\n\nTo see if stem cells from taste buds can be isolated in humans.\n\nEligibility:\n\nHealthy adults at least 18 years old\n\nDesign:\n\nParticipants will be screened with:\n\n* Medical history\n* Physical exam\n* Blood and urine tests\n* Tongue photograph and mouth inspection. Food coloring will be applied to the tongue.\n\nParticipants will have 1 study visit. They will not eat or drink anything 8 hours before.\n\n* They will give blood and urine samples.\n* They will have a tongue biopsy. Vital signs will be checked. The inside of the mouth will be examined. The tongue may be cleaned. The tongue will be numbed. Five small pieces of tissue will be taken with a small scissor. Any bleeding will be blotted with cotton and should stop in minutes.\n* Participants will be monitored for about 30 minutes. They will get a snack or meal.\n* They will be told how to take care of the tongue for the rest of the day.\n\nParticipants will be called a week later to see how the\n\n...",[26],[26,145,146,147],"Fungiform Papillae","Insulin","Natural History",{"date":118,"type":36},{"date":150,"type":36},"2017-12-18",{"date":152,"type":21},"2026-12-31",{"name":154,"class":43},"National Institute on Aging (NIA)",{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":16,"minAge":161,"maxAge":4,"enrollmentInfo":162,"targetDuration":164,"studyType":22,"phases":4,"briefSummary":165,"conditions":166,"keywords":169,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":182},"100617321","omnipod-5-a-french-prospective-multicentric-study-in-real-world-optimal-b-100617321","NCT07317102","Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)","Inclusion Criteria:\n\n* Patient with T1D aged ≥ 2 years.\n* Patient prescribed, less than a year ago, a commercially available confi guration of the Omnipod 5 System using a FreeStyle Libre 2 Plus sensor.\n* Patient has never used the Omnipod 5 System prior to inclusion.\n* Patient has not objected to the use of their personal data for this study.\n* Patient or legal guardian has an email address and mobile phone number.\n* Patient (and legal guardians if the patient is a minor) is able to understand study information and Non-Opposition form.\n* Patient (and legal guardians if the patient is a minor) is able to understand and complete questionnaires in French.\n* Patient is covered by the local social security system\n\nExclusion Criteria:\n\n* Patient is currently pregnant.\n* Patient presents an allergy to the materials of the Omnipod 5 System (patch, cannula, CGM).\n* Patient is unable to be followed by the same investigation site for the duration of the study or is unwilling or unable to maintain contact with the healthcare professional.\n* Patient is already participating in a clinical trial or in another study precluding their participation in other studies.\n* Adult under guardianship, curatorship or tutorship.\n* Adult otherwise deprived of liberty.","2 Years",{"count":163,"type":21},152,"12 Months","The purpose of this postmarket clinical investigation is to evaluate the levels of glycemic control, quality of life, and satisfaction, as well as the patient experience, and acute diabetes complication rates provided by the Omnipod 5 Automated Insulin Delivery System (referred to as the Omnipod 5 System) in a real-world setting.",[26,167,168],"Type 1 Diabetes","Diabetes Mellitus",[170,171,172],"Omnipod","Automated Insulin Delivery","Post-market Registry","2026-06-30",{"date":118,"type":36},{"date":176,"type":36},"2026-03-16",{"date":178,"type":21},"2027-11",{"name":180,"class":181},"Insulet Corporation","INDUSTRY",24,{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":140,"sex":16,"minAge":161,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":192,"conditions":193,"keywords":197,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":201,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":44},"100469897","a-natural-history-study-of-metabolic-sizing-in-health-and-disease-100469897","NCT05398783","A Natural History Study of Metabolic Sizing in Health and Disease","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all the following criteria for their cohort:\n\nCohort 1 - Healthy Volunteers\n\n* Male or female, aged \\>=2 years\n* In good general health as evidenced by medical history\n\nCohort 2 - Patients\n\n* Male or female, aged \\>=2 years\n* Diagnosed with diseases thought to alter metabolism or body composition (such as weight loss or gain, diabetes, renal disease, obesity, cancer, etc.) or taking medications thought to alter metabolism or body composition.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Participants over 200 kg due to the weight limit of the equipment.\n* Presence of any implanted device that would interfere with measurements.\n* Any moderate to severe limitations in mobility that would impede participation\n* Hemoglobin less than 10 g\u002FdL (in participants who would have blood drawn for research purposes).\n* Participants with dietary allergies, intolerances or eating patterns that would preclude them from consuming metabolic meals.\n* Participants unwilling or unable to give informed consent.\n* Participants with any other significant physical, medical, or psychiatric limitations, illness or conditions that may preclude them from completing the majority of the tests in this study per the discretion of the PI.","99 Years",{"count":191,"type":21},2000,"Background:\n\nScientists have long used simple measures (such as height and weight) to estimate how much a person s body uses food (calories) as energy, as commonly called the metabolic rate. But metabolism varies among people with similar body sizes. Scientists now believe the old formulas for estimating metabolic rates may not work well for all people. Researchers want to find more accurate ways to measure a person s metabolism.\n\nObjective:\n\nThis natural history study will examine the relationships between metabolism, body composition, and body surface area in a wide range of people.\n\nEligibility:\n\nHealthy children and adults aged 2 years or older. Also, people aged 2 years or older with conditions that may alter metabolism. These may include diabetes, obesity, renal disease, or cancer.\n\nDesign:\n\nParticipants will spend 2 days and 1 night in the hospital. They will provide a medical history and answer questions about their activity levels, the foods they eat, and their lifestyle. They will also eat a special diet.\n\nParticipants will undergo many tests:\n\nThey will lie in a bed with a clear hood covering their head for 30 to 45 minutes to measure the gases in their breath.\n\nThey will lie on a padded table for about 15 minutes while their body is scanned.\n\nThey will stand on a platform while a 3D scanner measures their body.\n\nThey will have a test to measure how fast an electric signal moves through their body.\n\nThey will grip an instrument to measure the strength of their hands.\n\nThey will drink salty water and provide blood and urine samples.\n\nParticipants may be invited to return for these 2-day visits up to 8 times per year. Return visits must be at least 2 weeks apart.",[27,194,195,26,196],"Cancer","Chronic Kidney Disease","Normal Physiology",[198,199,200,147],"Body Composition","Metabolism","Body Surface Area",{"date":116,"type":36},{"date":203,"type":36},"2022-10-25",{"date":205,"type":21},"2031-07-01",{"name":42,"class":43},{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":56,"phases":217,"briefSummary":218,"conditions":219,"keywords":220,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":44},"100644914","leveraging-interventions-for-needs-and-knowledge-in-diabetes-linkd-100644914","NCT07676188","Leveraging Interventions for Needs and Knowledge in Diabetes (LINKD)","Improving Diabetes Outcomes and Health Disparities by Addressing Unmet Resource Needs- A Sequential Multiple Assignment, Randomized Trial","LINKD","Inclusion Criteria:\n\nParticipants:\n\n* Age: 18 years of age or older\n* Diabetes diagnosis: Documented diagnosis of diabetes (Type 1 or Type 2) with prescribed anti-hyperglycemic medication\n* Glycemic control: Most recent (within the past 6 months) recorded hemoglobin A1c (HbA1c) level of: ≥7.5% for individuals ≤70 years of age and ≥8.0% for individuals between 70-75 years of age Prior study participation: Did not participate in the CareAvenue trial (R01DK116715)\n* Financial burden and\u002For social needs (meeting ONE or more of the following):\n\nPositive report of financial burden using validated screening questions; Medicaid or dual Medicare\u002FMedicaid coverage; Income ≤250% of the federal poverty level; Self-identified as ALICE (Asset-Limited, Income-Constrained, Employed): income above Medicaid threshold but reporting difficulty affording basic needs; Underinsured: high-deductible plan (≥$1,500 individual\u002F$3,000 family) with self-reported difficulty affording healthcare costs; Positive screen for one or more social risk factors on PRAPARE or equivalent (food insecurity, housing instability, transportation barriers, utility insecurity);\n\n* Financial decision-making: Self-identifies as primarily responsible for making own healthcare financial decisions (to address concerns about young adults dependent on family support).\n* Interest in assistance: Expresses interest in receiving assistance with unmet social needs.\n* Ability to participate: Able to complete the screening process in English (or Spanish\u002FArabic if materials available) on behalf of self.\n* Healthcare access: Receives or is able to receive care at Michigan Medicine (required for potential social worker referral).\n\nPeer Supporters:\n\n* Age: 18 years of age or older\n* Diabetes diagnosis: Self-reported diagnosis of diabetes (Type 1 or Type 2)\n* Glycemic control: Within the past 12 months, have had at least one hemoglobin A1c (HbA1c) level of: ≥7.5% for individuals ≤70 years of age and ≥8.5% for individuals ≥71 years of age, but have since had at least one A1c (HbA1c) level, including their most recent test, of: \\\u003C7.5% for individuals ≤70 years of age and \\\u003C8.5% for individuals ≥71 years of age\n* Experience navigating social or financial resources: Self-reported success in navigating financial assistance or social services resources\n* Ability to participate: Able to provide peer support in English (option to additionally provide support in Spanish and\u002For Arabic); Able to complete training; Able to make calls every other week with assigned participants; Able to submit call logs; Able to complete a brief survey about experience throughout participation.\n* Confidence in diabetes self-management: Self-reported confidence in ability to manage diabetes\n\nExclusion Criteria:\n\nParticipants:\n\n* Serious psychiatric disorder: Active diagnosis of schizophrenia, active psychosis, or other serious mental illness that would impair ability to engage in intervention (as determined by medical record review)\n* Cognitive impairment: Documented moderate to severe cognitive impairment that would prevent meaningful participation in study activities (as determined by medical record review)\n* Active substance use: Current active illicit drug use that would interfere with study participation (as determined by medical record review)\n* Pregnancy: Currently pregnant or planning pregnancy during the study period (due to expected A1c changes) (as determined by medical record review)\n* Glucose-altering medications: Currently taking medications that alter glucose metabolism as a side effect rather than for diabetes management, including: Chronic oral corticosteroids (≥2 weeks continuous use); Antipsychotic medications known to affect glucose; Other medications affecting glucose when NOT prescribed for diabetes management Note: GLP-1 agonists, SGLT2 inhibitors, and other diabetes medications are NOT excluded, regardless of whether they are also used for weight management\n* Limited life expectancy: Self-reported or documented comorbidity expected to limit life span to less than 3 years\n* Concurrent diabetes study participation: Currently enrolled in another diabetes intervention study\n* Institutionalized: Currently residing in a nursing home, assisted living facility, correctional facility, or another group setting that prevents them from participating on their own behalf\n\nPeer Supporters:\n\n* Cognitive impairment: Self-reported cognitive impairment that would prevent meaningful participation in study activities\n* Participation Concerns or Barriers: Self-reported concerns that would prevent meaningful participation in study activities\n* Limited life expectancy: Self-reported or documented comorbidity expected to limit life span to less than 3 years\n* Institutionalized: Currently residing in a nursing home, assisted living facility, correctional facility, or another group setting that prevents them from participating on their own",{"count":216,"type":21},694,[88],"Unmet social needs and economic burden persist as key reasons why one-third of people with diabetes have poor disease control. The purpose of this study is to learn whether different tools and types of support may help people manage diabetes and related challenges. The study will compare several approaches to understand how they affect people's experiences and health over time. Completion of the study aims will lead to an optimized intervention to improve the health and social well-being of people with diabetes.\n\nParticipants will be randomly assigned to one or more interventions aimed at addressing social and financial needs and will complete multiple surveys over the course of a year. The study team will collect information about their blood pressure and HbA1c (blood glucose).\n\nFindings will advance the field by determining the effectiveness of supportive interventions to address both social needs and diabetes self-care, and by informing protocols for the optimal sequencing of these strategies, a critical evidence gap in healthcare settings.",[26],[26,221,222,223,224],"Intervention Strategies","Social Support","Financial Support","Disease Management","2026-06-29",{"date":116,"type":36},{"date":228,"type":21},"2026-07",{"date":230,"type":21},"2030-07-31",{"name":232,"class":110},"University of Michigan",{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":140,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":241,"conditions":242,"keywords":245,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":4,"leadSponsor":254,"locationsCount":256},"100083273","personalized-environment-and-genes-study-100083273","NCT00341237","Personalized Environment and Genes Study","* INCLUSION CRITERIA\n\nIn order to be eligible for participation in this study, an individual must meet all of the following criteria:\n\n* Adults greater than or equal to 18 years of age\n* If female, must not be (self-reported as) pregnant. At the time of enrollment, a pregnancy test will only be done at the PI s discretion.\n* Able to understand and provide written informed consent\n* Able to come to the NIEHS Clinical Research Unit (CRU) for enrollment and study-related visits\u002Fprocedures.\n\nEXCLUSION CRITERIA\n\nAn individual who does not meet the inclusion criteria listed above is excluded from participation in this study.",{"count":240,"type":21},25000,"Despite the overwhelming focus on genetic and genomic causes of human disease over the past two decades, it has been estimated that genetics is currently known to explain only 20% and 40% of the etiology of common disease. Thus, it is becoming increasingly apparent that human disease is a consequence of both genetic susceptibility and environmental exposures. Importantly, while individuals cannot change their genetic composition, we do have the ability both personally and as a society, to influence our environment, promoting health and decreasing the risk of disease. The Personalized Environment and Genes Study (PEGS) aims to determine how the environment and gene-environment interactions can inform our understanding of human health and disease. As science has evolved, so too has the science of this project. This evolution was reflected in a change in the title of this project from the Environmental Polymorphisms Registry (EPR) to the Personalized Environment and Genes Study (PEGS) to more accurately reflect the science that can be conducted. PEGS is a unique resource because of the depth of environmental phenotyping which includes extensive information from exposome surveys, as well as whole genome sequencing on a significant number of participants in the cohort. While it is small relative to genomic cohorts, none of these have the extensive environmental data that is present in PEGS. In addition, other cohorts with deep environmental data lack the depth of genomic data that is present in PEGS. Importantly, PEGS has already provided important analytic advances that are of great interest to and can be confirmed in larger cohorts such as All of Us.\n\nThe Personalized Environment and Genes Study (PEGS) aims to provide a resource for environmental health translational research by examining gene-environment interactions in health and disease. PEGS is an extension of two previous efforts where it began as a pilot study, the Environmental Polymorphisms Study (EPS; IRB# 02E9004) and was approved subsequently as a full protocol titled the Environmental Polymorphisms Registry (EPR) (IRB #04-E-N0053 and transitioned to its current ID# 04-E-0053). The EPR was envisioned as a phenotype-by-genotype registry of participants who had donated DNA samples, and who had agreed to be contacted for follow-up clinical translational studies based on their DNA genotypes. At the time, the only information available was a participant s age, sex, race, and ethnicity. Further phenotyping of a participant and\u002For any biospecimens obtained were investigated during a follow-up translational clinical study on participants recruited based on their genotype (hence phenotype-by-genotype) and the PEGS was the first recruit-by- genotype study at the NIH. Following a period focused on recruiting approximately 15,000 participants to enable genotyping of rare (approximately 1% minor allele frequency) single nucleotide polymorphisms (SNPs), the PEGS Consortium Project was undertaken in 2010- 2011 to examine, using the DNA of nearly 4,000 participants, approximately 700 SNPs in approximately 80 environmental response genes that work in concert with environmental exposures to elicit a phenotype. Several clinical follow-up studies, genotype-phenotype association studies, and publications have resulted from the PEGS Consortium Project.\n\nTo expand phenotype information available to researchers, the Health and Exposure Questionnaire was administered between 2013-2014. In 2017, a more detailed Exposome Questionnaire which includes questions relating to the external and internal exposome was administered. This was an important resource through which to integrate exposures with genotype-phenotype association studies.\n\nWhole genome sequencing has now been performed on approximately 4700 participants who were reconsented for this purpose, as indicated above. Questionnaire data was fully adjudicated and combined in a robust and searchable database. With the increased power of the data available, the project was renamed as the Personalized Environment and Genes Study (PEGS) and rolled out in Sept. 2021.",[26,243,244],"Heart Disease","Asthma",[246,247,248,249,147],"Genotype","Phenotype","Environmental Factor","Single Nucleotide Polymorphism","2026-06-27",{"date":173,"type":36},{"date":253,"type":36},"2010-05-26",{"name":255,"class":43},"National Institute of Environmental Health Sciences (NIEHS)",2,{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":4},"100645396","global-long-term-outcomes-and-real-world-evaluation-of-dexcom-continuous-glucose-monitoring-system-dexcom-glow-100645396","NCT07681024","Global Long-term Outcomes and Real-World Evaluation of Dexcom Continuous Glucose Monitoring System (Dexcom GLOW)","Inclusion Criteria:\n\n* \"1. Meets Dexcom CGM System Indications for Use (IFU) per approved commercial labeling\n* 2\\. Has at least one HbA1C (Hemoglobin a1c) measurement obtained within the three (3) months prior to the start date of first Dexcom CGM System use in the study (blinded or unblinded, whichever first). For participants with prior CGM experience (CGM non-naive), this HbA1c measurement must also be at least three (3) months after the end of any CGM usewithin three (3) months prior to the Dexcom CGM System use start date that is at least three (3) months after any prior CGM use\n* 3\\. Participant is willing and able to use Dexcom CGM System according to approved product labeling\n* 4\\. Participant is willing and able to complete applicable patient reported outcome assessments\u002F surveys\n* 5\\. Participant is willing and able to comply with the Clinical Investigation Plan\n* 6\\. Participant is willing and able to comply with provider requirements for at least one or more provider encounters after CGM initiation according to applicable clinical practice guidelines\n* 7\\. Participant or the participant's legally authorized representative must provide written informed consent prior to any study-related data collection or be enrolled under an IRB\u002FEC\u002FREB approved waiver of consent\"\n\nExclusion Criteria:\n\n* \"1. Is contraindicated for a Dexcom CGM System per approved commercial labeling\n* 2\\. In the Investigator's opinion, the participant is not considered to be a suitable candidate\n* 3\\. Currently participating in another study and receiving and intervention study\"",{"count":264,"type":21},5000,"Global Registry study",[26],"2026-06-26",{"date":118,"type":36},{"date":270,"type":21},"2026-06-15",{"date":272,"type":21},"2030-05-01",{"name":274,"class":181},"DexCom, Inc.",{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":140,"sex":84,"minAge":283,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":56,"phases":286,"briefSummary":287,"conditions":288,"keywords":291,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":297,"leadSponsor":299,"locationsCount":44},"100619937","improving-cervical-cancer-prevention-among-women-living-with-chronic-conditions-100619937","NCT07351110","Improving Cervical Cancer Prevention Among Women Living With Chronic Conditions.","Improving Cervical Cancer Prevention Among Women Living With Chronic Conditions. Aim 3: Assess the Feasibility and Acceptability of the PINPOINT Intervention.","PINPOINT","Inclusion Criteria:\n\nThe following eligibility criteria will be used to determine inclusion into the study:\n\n1. Using the American Cancer Society (ACS) screening recommendations, adults aged over the age of 25 will be eligible\n2. Active UF Internal Medicine patient and has had an appointment in the last 2 months.\n3. Assigned sex at birth is female\n4. Have Obesity or Type 2 Diabetes\n5. Not currently pregnant (self-report)\n6. Have not given birth in the prior 12 weeks\n7. No previous history of cervical cancer\n8. No previous history of a hysterectomy\n9. Have not undergone cancer screening in the past 3 years or more\n10. Reside in the UFHCI Catchment Area (Alachua, Baker, Bradford, Citrus, Clay, Columbia, Dixie, Gadsden, Gilchrist, Hamilton, Jefferson, Lafayette, Lake, Leon, Levy, Madison, Marion, Putnam, Sumter, Suwannee, Taylor, UnioF1n, or Wakulla County).\n11. Have a mobile phone or access to a mobile phone that can be used to receive messages, or a valid email address.\n12. Are not currently scheduled to receive cervical cancer screening via clinician sampling (pap smear).\n\nExclusion Criteria:\n\n* Previous history of cervical cancer\n* Total hysterectomy\n* Pregnant","25 Years",{"count":285,"type":21},20,[88],"Our overarching goal is to adapt and test the PINPOINT intervention -PatIent Navigation for the Prevention of CervIcal CaNcer inTervention. We will test the PINPOINT intervention among patients with high-risk profiles for cervical cancer who do not meet the recommended screening for cervical cancer.",[26,289,290],"Cervical Cancer (Early Detection)","Obesity & Overweight",[292,293,294],"cervical cancer screening","self-collection","self-sampling",{"date":173,"type":36},{"date":173,"type":21},{"date":298,"type":21},"2027-03-24",{"name":300,"class":110},"University of Florida",{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":16,"minAge":309,"maxAge":310,"enrollmentInfo":311,"targetDuration":4,"studyType":56,"phases":313,"briefSummary":314,"conditions":315,"keywords":317,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":326,"leadSponsor":328,"locationsCount":330},"100645080","polypills-approach-for-multiple-cardiovascular-risk-factors-100645080","NCT07679828","Polypills Approach for Multiple Cardiovascular Risk Factors","Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF) : a Multicentre, Open-label, Randomized Controlled Trial","PACIF","Inclusion Criteria:\n\n* Men or women\n* Age ≥50 years and \\\u003C75 years\n* Hypertension, defined as systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg among participants not currently taking antihypertensive medication, or systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg among participants currently taking any antihypertensive medication\n* Dyslipidemia, defined as LDL-C ≥1.8 mmol\u002FL (70 mg\u002FdL)\n* Type 2 diabetes with HbA1c ≥6.5% and \\\u003C12%\n* Willing to participate and able to sign informed consent\n\nExclusion Criteria:\n\n* Known secondary cause of hypertension\n* Type 1 diabetes\n* Pancreatic insufficiency or diabetes secondary to pancreatitis\n* Triglycerides ≥5.65 mmol\u002FL (500 mg\u002FdL)\n* History of coronary, carotid, or cerebrovascular revascularization within the previous 12 months\n* History of myocardial infarction or stroke within the previous 6 months\n* NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months\n* Abnormal kidney function, defined as estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m² or dialysis\n* Abnormal liver function, defined as alanine aminotransferase or aspartate aminotransferase \\>3 times the upper limit of normal\n* Abnormal serum potassium, defined as serum potassium \\>5.5 mmol\u002FL or \\\u003C3.5 mmol\u002FL\n* Contraindication to any of the components of the polypill\n* Currently living with another PACIF participant\n* Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control\n* Clinical diagnosis of dementia or treatment with medications for dementia\n* History of malignancy\n* Life expectancy \\\u003C3 years\n* Currently participating in another intervention study\n* Any factors judged by the clinic team to be likely to limit adherence to interventions","50 Years","75 Years",{"count":312,"type":21},8252,[88],"The Polypill Approach for Multiple Cardiovascular Risk Factors (PACIF) trial is a multicenter randomized controlled trial that will test the effectiveness and safety of a fixed-dose combination strategy for integrated management of hypertension, dyslipidemia, and diabetes among adults aged 50 to 75 years in China. The trial will evaluate whether a simplified regimen combining blood pressure-lowering, lipid-lowering, and glucose-lowering therapy improves the 10-year cardiovascular disease risk score at phase 1. Participants will be followed to determine whether the fixed-dose combination strategy reduces major cardiovascular events and cognitive function compared with usual care at phase 2.",[91,316,26],"Dyslipidemia",[91,316,26,318,319,320,321,322],"Polypill","Cardiovascular disease risk","Cardiovascular Diseases","Cognitive function","Randomized controlled trial","2026-06-25",{"date":116,"type":36},{"date":116,"type":21},{"date":327,"type":21},"2030-03-01",{"name":329,"class":110},"China Medical University, China",12,{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":16,"minAge":18,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":56,"phases":340,"briefSummary":341,"conditions":342,"keywords":344,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":44},"100635557","auricular-acupuncture-therapy-administered-by-village-doctors-improves-sleep-quality-in-elderly-patients-with-comorbid-diabetes-mellitus-and-hypertension-100635557","NCT07554235","Auricular Acupuncture Therapy Administered by Village Doctors Improves Sleep Quality in Elderly Patients With Comorbid Diabetes Mellitus and Hypertension","Auricular Acupuncture Therapy Administered by Village Doctors Improves Sleep Quality in Elderly Patients With Comorbid Diabetes and Hypertension","Inclusion Criteria:\n\n1. Age ≥65 years;\n2. Patients with comorbid diabetes mellitus and hypertension:\n3. Sleep disturbance: Pittsburgh Sleep Quality Index (PSQI) total score ≥8;\n4. Willing to participate in this study and sign the informed consent form;\n5. Has resided in this village for at least six months.\n\nExclusion Criteria:\n\n1. Stroke;\n2. Severe mental illness or cognitive impairment;\n3. Severe organ failure (e.g., end-stage renal disease);\n4. Ear infection, eczema, breakage, or deformity;\n5. Currently receiving regular other acupuncture treatments;\n6. Use of any hypnotic medications within the past month\n7. Bleeding disorders or use of anticoagulants (increased bleeding risk);\n8. History of fainting during acupuncture;\n9. Life expectancy less than six months.",{"count":339,"type":21},320,[88],"This study aims to apply traditional auricular press-needle acupuncture to treat sleep disturbances in elderly patients (aged ≥65 years) with comorbid diabetes mellitus and hypertension in rural areas of China. Given the complex bidirectional relationship between diabetes mellitus with hypertension and sleep disturbances, this cluster randomized trial is designed to test whether a village doctor-led intervention model supported by telemedicine can improve sleep disturbances in patients with comorbid diabetes mellitus and hypertension, compared to sham auricular press-needle acupuncture. Participants will be recruited by local village doctors according to the inclusion and exclusion criteria. The protocol is based on Traditional Chinese Medicine theory for core point selection: Heart, Liver, Kidney, Shenmen, and Forehead area, along with optimized medication regimens supported by remote cardiovascular specialists. The investigators will evaluate the overall improvement in sleep disturbances using the Pittsburgh Sleep Quality Index (PSQI) at the end of the 6-week treatment period, and assess sleep disturbances, anxiety, depression, daytime sleepiness, and fatigue at 12 weeks.",[343,26,91],"Insomnia Disorder",[345,346,91,26,347],"Village Doctors","Acupuncture needles","insomnia",{"date":225,"type":36},{"date":350,"type":36},"2026-04-22",{"date":352,"type":21},"2027-02-20",{"name":354,"class":110},"Jiangsu Taizhou People's Hospital",{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":140,"sex":16,"minAge":52,"maxAge":362,"enrollmentInfo":363,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":365,"conditions":366,"keywords":371,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":44},"100439876","caregiving-networks-across-disease-context-and-the-life-course-100439876","NCT05007990","Caregiving Networks Across Disease Context and the Life Course","Caregiving Networks Across Disease Context and the Life Course: A Comparative Longitudinal Study","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Adults aged 18 years and older\n* If the Care Recipient is living, they must self-identify as a primary caregiver to the Care Recipient (individual with a chronic medical condition), OR if the Care Recipient is deceased, they must self-identify as having been a primary caregiver to the now-deceased Care Recipient, OR they must otherwise be identified (i.e., referred) by a participant as a part of the caregiving network\n* Ability to consent to research\n* Fluency in English will be needed to complete interview as well as to read, comprehend surveys and consent forms, as appropriate validated measures in other languages are not readily available.\n* Physically capable of participating in applicable assessments\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from this study:\n\n* Care Recipients (as defined in this protocol)\n* Staff of NHGRI\n\nStaff of NHGRI are unable to participate in this study as a safeguard against the risk of ethical concerns. As per OHSRP SOP 404, NIH staff may be a vulnerable class of study subjects. Excluding staff of the Institute conducting the study assures there will not be any perceived or actual conflict of interest, pressure\u002Fcoercion to participate among co-workers, subordinates, work unit-members, etc. As further noted in OHSRP SOP 404, exclusion further protects this class of subjects privacy and confidentiality; and protects the study s scientific integrity.\n\nPersons with impaired neuro-sensory or decision-making ability (adults unable to provide consent) will not be enrolled in the study. Persons with impaired neuro-sensory or decision making ability would not be able to participate with independent responses to the various social behavioral measures we use in the study interview and survey. Learning information about these individuals through other people instead of themselves would introduce bias to this study.","100 Years",{"count":364,"type":21},2800,"Background:\n\nIn the U.S., about 53 million informal, unpaid caregivers provide care to a person who is ill, is disabled, or has age-related loss of function. These caregivers may be adult children, spouses, parents, or others. The stress of providing long-term care affects caregivers health and well-being. Researchers want to learn more about this stress and its effects.\n\nObjective:\n\nTo learn how the caregiving process affects the health and well-being of caregivers over time.\n\nEligibility:\n\nAdults aged 18 years and older who are caregivers for a person with a chronic medical condition and who have already given consent to take part in other study activities.\n\nDesign:\n\nParticipants will be put in different groups. They will complete some or all of the following tasks over 1 year. They may repeat these tasks once a year for up to 5 years.\n\nParticipants will fill out 2 online surveys. One will ask about their health and their caregiving experience. The other will ask them to list people in their social network and their care recipient s social network who give them support.\n\nParticipants will have a 2-part phone interview. It will be audio recorded. In part 1, they will be asked about the people they listed in the survey. In part 2, they will be asked about their caregiving experience and events in the care recipient s life.\n\nParticipants may fill out a weeklong diary every 3 months. It will ask about their daily social activities, well-being, and stress levels. It will also ask about their thoughts and feelings about caregiving.\n\nParticipants may give a blood sample each year they are in the study.\n\n...",[367,368,369,370,26],"Inherited Metabolic Disorders","Undiagnosed Diseases","Batten's Disease","Tay Sachs",[222,372,147,373,374],"Rare Diseases","Genetic Conditions","Family Network",{"date":267,"type":36},{"date":377,"type":36},"2022-09-08",{"date":379,"type":21},"2030-12-31",{"name":381,"class":43},"National Human Genome Research Institute (NHGRI)",{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":56,"phases":391,"briefSummary":392,"conditions":393,"keywords":410,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":256},"100526751","effect-of-endoscopic-sleeve-gastroplasty-in-patients-with-obesity-and-mash-a-randomized-controlled-trial-100526751","NCT06138821","Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial","Effect of Endoscopic Sleeve Gastroplasty on Patients With Obesity and Concomitant Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Multicenter, Open-label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 (male or female)\n2. BMI ≥30 kg\u002Fm2 or ≥27 kg\u002Fm2 with at least one obesity-related comorbidity\n3. Self-reported stable weight (no weight change \\>5%) for 6 months prior to the first study visit\n4. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory\u002Fimaging\u002Fadditional tests, and completing diet counseling\n5. Willingness to NOT start a new anti-obesity medication for the following 12 months\n6. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete routine follow-up visits\n7. Ability to give informed consent\n8. Women of childbearing potential (i.e., not post-menopausal, nor surgically sterilized) must agree to use adequate birth control methods\n\nExclusion Criteria:\n\n1. Known history of other chronic liver diseases (viral hepatitis, autoimmune hepatitis, drug-induced hepatitis, and genetic)\n2. Treatment with vitamin E (at doses ≥800 IU\u002Fday), pioglitazone, obeticholic acid, or resmetirom \\\u003C90 days before the first study visit\n3. History of foregut or gastrointestinal (GI) surgery (except uncomplicated fundoplication, cholecystectomy or appendectomy)\n4. Prior bariatric surgery\n5. Prior endoscopic sleeve gastroplasty\n6. Any inflammatory disease of the GI tract, including severe (LA Grade C or D) esophagitis, Barrett's esophagus with dysplasia, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease\n7. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses\n8. Severe gastroesophageal reflux disease (GERD)\n9. A structural abnormality in the esophagus or pharynx, such as a stricture or diverticulum, that could impede passage of the endoscope.\n10. Achalasia or any other severe esophageal motility disorder\n11. Chronic abdominal pain\n12. Gastroparesis or intractable constipation\n13. Hepatic insufficiency or cirrhosis\n14. Severe coagulopathy\n15. Insulin-dependent diabetes (either type 1 or type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or HgbA1C ≥ 12%\n16. Patients on an anti-platelet agent, anticoagulant agent or chronic\u002Froutine use of NSAIDs\n17. Patients on corticosteroids, immunosuppressants, or narcotics\n18. Patients on an anti-seizure or anti-arrhythmic medication\n19. Patients who are pregnant or breastfeeding\n20. Excessive alcohol consumption (\\>20 g per day for women; \\>30 g per day for men)\n21. Active smoking\n22. History of poorly controlled hypertension, coronary artery disease, congestive heart failure, cardiac arrhythmia\n23. History of respiratory diseases such as chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer\n24. History of autoimmune connective tissue disorder such as lupus, scleroderma or immunocompromised disease\n25. History of active malignancy\n26. History of genetic or hormonal causes for obesity, such as Prader Willi syndrome\n27. History of endocrine disorders affecting weight, such as uncontrolled hypothyroidism\n28. Eating disorders, including night eating syndrome, bulimia, binge eating disorder or compulsive overeating\n29. Active psychological issues preventing participation in a lifestyle modification program as determined by a psychologist",{"count":390,"type":21},132,[88],"Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. On the other end of the spectrum, bariatric surgery has shown promise in the treatment of MASLD\u002Fmetabolic dysfunction-associated steatohepatitis (MASH) due to its efficacy in inducing weight loss. Nevertheless, its adoption has been hindered by the perceived invasiveness of surgery.\n\nOver the past decade, endoscopic sleeve gastroplasty (ESG) has gained recognition as a promising minimally-invasive approach to weight loss. The procedure involves utilizing a Food and Drug Administration (FDA)-authorized endoscopic suturing device to reduce the gastric volume by 70%. Studies reveal that ESG is associated with approximately 18.2% weight loss at one year after the procedure, with sustained results for at least 10 years. Nevertheless, the effect of ESG on MASH remains unknown.\n\nIn this study, the investigators will compare ESG + lifestyle modification versus lifestyle modification alone in treating histologic MASH. The study will randomize patients to one of two different treatment options: ESG + lifestyle modification or lifestyle modification alone.",[25,394,395,396,397,398,399,400,401,402,403,404,31,26,405,406,407,408,409],"Liver Diseases","Liver Fibrosis","Liver Fat","Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Dysfunction-Associated Steatohepatitis","MASLD","MASH","Weight Loss","Insulin Resistance","Insulin Sensitivity","Insulin Sensitivity\u002FResistance","Diabetes Mellitus, Type 2","NASH With Fibrosis","Non-Alcoholic Fatty Liver Disease","Non Alcoholic Fatty Liver","Non-alcoholic Steatohepatitis",[411,412,413,414,415,416,417,418,419,420,421,422,423],"Gut Hormones","Endoscopic Bariatric and Metabolic Therapy (EBMT)","Intragastric Balloon (IGB)","Endoscopic Suturing","Endoscopic Sleeve Gastroplasty (ESG)","Weight Management","Endoscopic Gastric Remodeling (EGR)","Endoscopic Bariatric Therapy (EBT)","Fatty Liver","Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Non-Alcoholic Fatty Liver Disease (NAFLD)","Non-Alcoholic Steatohepatitis (NASH)","2026-06-23",{"date":323,"type":36},{"date":427,"type":36},"2025-06-24",{"date":429,"type":21},"2028-06",{"name":431,"class":110},"Pichamol Jirapinyo, MD, MPH",{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":44},"100637770","changing-outpatient-diabetes-care-with-remote-patient-monitoring-a-real-world-evidence-study-with-pre-post-comparison-100637770","NCT07617519","Changing Outpatient Diabetes Care With Remote-Patient-Monitoring: A Real World Evidence Study With Pre-Post Comparison","Inclusion Criteria:\n\n* All people with active clinical care at SDCC during each period and thereby included in the RPM.\n\nExclusion Criteria:\n\n* All people without active clinical care at SDCC during each period.",{"count":439,"type":21},12000,"The goal of this observational pre-post study is to evaluate a remote-patient-monitoring-system (RPM-system) integrated within an electronic health record (EHR) system in a real world cohort of approximately 12.000 people with diabetes in an outpatient care setting. The main question it aims to answer is:\n\nWhether glycemic outcomes following integration of the RPM system into the EHR over a two-year period are non-inferior compared with outcomes observed prior to an ambulatory care restructuring (including a prototype of the RPM-system) in October 2024.\n\nParticipants are included in the RPM-system as part of their regular medical care for diabetes.",[26,442,443,444,445,446],"Diabetes Care","Diabetes Type 1","Diabetes Type 2","Remote Patient Monitoring","Digital Health","2026-06-22",{"date":323,"type":36},{"date":450,"type":21},"2026-06",{"date":452,"type":21},"2028-07",{"name":454,"class":110},"Steno Diabetes Center Copenhagen",{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":459,"acronym":460,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":56,"phases":463,"briefSummary":465,"conditions":466,"keywords":470,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":256},"100594271","phase-4-glucagon-like-peptide-1-receptor-agonists-in-patients-receiving-maintenance-dialysis-100594271","NCT07017270","Glucagon-like-peptide-1 Receptor Agonists in Patients Receiving Maintenance Dialysis","GUARD-1","Inclusion Criteria:\n\n1. Age ≥ 18\n2. Receiving chronic maintenance hemodialysis or peritoneal dialysis for ≥ 90 days\n3. confirmed DM2 based on medical history and current or prior receipt of an oral hypoglycemic agent and\u002For insulin.\n4. Ability to provided informed consent or through their substitute decision maker\n\nExclusion Criteria:\n\n1. Type 1 DM\n2. Use of a GLP-1-RA within 30 days prior to screening\n3. Personal or first-degree relative(s) with a history of type 2 multiple endocrine neoplasia syndrome or medullary thyroid cancer, or acute pancreatitis (within 180 days of study screening)\n4. Confirmed pregnancy, women of childbearing potential\n5. Known hypersensitivity to GLP-1-RA\n6. Expected to recover kidney function, stop hemodialysis, pursue palliative care, or transplantation within 6 months\n7. Enrolment in another clinical trial judged by the investigator to interact with the effect of GLP1-RA",{"count":55,"type":21},[464],"PHASE4","This study aims to determine if GLP1RA is safe and tolerable in maintenance dialysis population, adherence, and feasibility of a larger definitive cardiovascular outcome trial in this population. Participants will be randomized 1:1 to either weekly subcutaneous semaglutide versus usual care and followed for 26 weeks.",[467,26,468,469],"Kidney Disease, Chronic","Dialysis","End Stage Kidney Disease (ESRD)",[468,471,472,473,474,475],"Type 2 diabetes","semaglutide","end stage kidney disease","GLP1","GLP1RA",{"date":267,"type":36},{"date":478,"type":36},"2025-11-27",{"date":480,"type":21},"2027-09",{"name":482,"class":110},"Unity Health Toronto",{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":140,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":44},"100478107","circulating-biomarkers-in-the-development-of-type-1-diabetes-100478107","NCT05505669","Circulating Biomarkers in the Development of Type 1 Diabetes","Circulating Biomarkers of Beta Cell Loss\u002FDysfunction in Diabetes","Inclusion Criteria:\n\n* Documented informed consent\u002F assent from the subject\n* ONE of the following:\n\n  * Type 1 diabetes patients (including pediatric patients) -OR-\n  * Adult type 2 diabetes patients -OR-\n  * Volunteers who are islet auto-antibody positive (i.e. insulin, GAA, IA-2, IAA and ZnT8 antibodies) with HbA1c ≤ 5.6% (including pediatric patients)-OR-\n  * Adult participants with clinical diagnosis of high blood sugar (i.e. HbA1c of 5.7% to 6.4%)-OR-\n  * Adult control subjects with HbA1cc ≤ 5.6%\n* Weight ≥ 30 kg\n* Willingness to: Provide blood sample(s) and if applicable: permit medical record\u002F clinical laboratory result review\n\nExclusion Criteria:\n\n* Control subjects must not have any chronic conditions or have undergone cellular, tissue or organ transplant\n* Sickle cell disease or anemia (exception: anemia that is corrected with treatment and source documents confirm corrected blood parameters current within 6 months of blood draw)\n* Active infection\n* Active malignancy (i.e., currently undergoing treatment)\n* Immunomodulatory therapy within 1 year of planned blood draw (may include immune checkpoint inhibitors, thalidomide, lenalidomide, pomalidomide, imiquimod, Bacillus Calmette-Guérin, and cytokines\u002F growth factors (e.g. interferons, interleukins)\n* Type 1 diabetes only: polyclonal regulatory T cell and\u002For dendritic cell therapy\n* Bleeding disorder\n* Women of childbearing potential: Pregnant\u002F nursing (Note: Eligibility may be deferred per blood donation timelines for pregnancy\u002Fnursing)\n* Diabetic patients only: Any clinical condition that might be adversely affected by the removal of up to 100 mL of blood\n* An employee who is under the direct\u002F indirect supervision of the PI\u002F a co-investigator\u002F the study manager\n* A direct study team member",{"count":491,"type":21},165,"More than 100 million U.S. adults are now living with diabetes or prediabetes. Investigators still do not fully understand how diabetes develops and how the disease worsens. Insulin is a hormone that helps the body use sugar as a fuel and control blood-sugar levels. People with diabetes have problems making insulin. This is because their insulin-producing beta cells -in the pancreas-are damaged or destroyed. A biomarker is a biological molecule (such as DNA, RNA (the genetic material of cells) or protein) that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker can be measured and found in blood and\u002For other body fluids (such as saliva and urine). Understanding the biology of beta cells could help find diabetes-related biomarkers. The discoveries from this research could help with early diagnosis of diabetes and lead to the creation of therapies for treating diabetes.",[26],{"date":495,"type":36},"2026-06-24",{"date":497,"type":36},"2022-03-29",{"date":499,"type":21},"2029-06-21",{"name":501,"class":110},"City of Hope Medical Center",{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":509,"conditions":510,"keywords":511,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":516,"leadSponsor":518,"locationsCount":44},"100644163","pilot-usability-study-to-set-up-and-use-the-feetsee-foot-monitoring-device-in-adults-with-diabetes-100644163","NCT07666087","Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device in Adults With Diabetes","Inclusion Criteria:\n\n* Males and females aged 18 years or older\n* Clinical diagnosis of Type 1 or Type 2 diabetes\n* At least one palpable foot pulse per feet\n* Possess basic ability to use a smartphone or tablet\n* Have no prior experience with the Feetsee™ system\n* Be willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Active foot ulceration at enrollment\n* Active Charcot neuro-osteoarthropathy\n* Severe vascular disease (complete absence of foot pulses)\n* Amputation of more than three toes\n* Active malignancy or immunosuppressive condition\n* Cognitive or physical impairments preventing proper device usage\n* Concurrent participation in another investigational study with contraindicated procedures",{"count":285,"type":21},"Single-center, prospective, minimal-risk, non-experimental usability study assessing the setup and use of the FDA-registered (Class I medical device; 510(k)-exempt) Feetsee™ home foot-monitoring system by adults with diabetes in their home environment over 8 weeks.\n\nThis study in non clinical, observational pilot usability study conducted under FDA Human Factors and Usability Engineering guidance (2016).",[26],[512],"Foot monitoring","2026-06-18",{"date":495,"type":36},{"date":33,"type":21},{"date":517,"type":21},"2027-07-10",{"name":519,"class":181},"Diabetis JSC",{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":56,"phases":529,"briefSummary":530,"conditions":531,"keywords":539,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":550,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":44},"100626901","families-implementing-good-health-traditions-for-life-100626901","NCT07441655","Families Implementing Good Health Traditions for Life","FIGHT for Life","Inclusion Criteria:\n\n1. Family 1.a.) Black Parent\u002FGuardian: age 18 years or older residing in the same household with child (i.e., biological or have legal guardianship for child) 1.b.) Child: age 8-15 years old\n2. Parent\u002FGuardian have HbA1c level 5.7-6.4% (prediabetes)\n3. Parent\u002FGuardian willing to commit to participation in a 20-month research study and have no plans to move from the area over the next 20-months\n4. Parent\u002Fchild are ambulatory and able to participate in physical activity\n\nExclusion Criteria:\n\n1. Individuals with severe psychological disorders that may prevent\u002Finterfere with study participation\n2. Physical impairments that may prevent participation in moderate intensity physical activity;\n3. Previous diagnosis of diabetes\n4. History of congestive heart failure, renal failure, or recent (\\\u003C12 months) cardiovascular events such as myocardial infarction or stroke;\n5. Person taking medications that may affect endpoint analyses\n6. Persons with co-morbid contraindications to physical activity or dietary changes.\n7. Currently pregnant or planning to become pregnant in the next year.",{"count":528,"type":21},70,[88],"This study will provide evidence for the utility of using a community-engaged research approach to implement a tailored, family-oriented adaptation of the Diabetes Prevention Program that will have positive effects on risk factors associated with type 2 diabetes morbidity and mortality among Black families in a Southwest Georgia community.",[26,100,532,533,534,535,536,537,538],"Type 2 Diabetes","Healthy Lifestyle","Nutrition, Healthy","Sedentary Behavior","Family","Family Research","Family and Household",[540,541,542,543,544,545,546,547,548,549],"diabetes","rural","type 2 diabetes","nutrition","physical activity","diabetes prevention","family research","family and household","chronic disease","sedentary behavior",{"date":424,"type":36},{"date":552,"type":36},"2026-02-04",{"date":554,"type":21},"2028-04-30",{"name":556,"class":110},"Morehouse School of Medicine",{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":563,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":565,"enrollmentInfo":566,"targetDuration":4,"studyType":56,"phases":568,"briefSummary":569,"conditions":570,"keywords":574,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":580,"completionDateStruct":581,"leadSponsor":583,"locationsCount":44},"100641620","phase-2-reducing-inflammation-to-improve-vascular-and-bone-outcomes-with-low-dose-colchicine-in-ckd-100641620","NCT07654231","Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD","Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD: A Pilot Randomized Open-Label Trial (RESOLVE-CKD Trial)","RESOLVE-CKD","Inclusion Criteria:\n\n* Men and women aged 18-\\\u003C70 years of all race\u002Fethnicity groups\n* CKD stage 3 (estimated glomerular filtration rate (eGFR) \\>30 to 59 ml\u002Fmin\u002F1.73m2)\n* Urine albumin-to-creatinine ratio (uACR) ≥ 200 mg\u002Fg\n* Cardiac artery calcification (CAC) Agatston score ≥30\n* Hypertension, diabetes, dyslipidemia, or established atherosclerotic cardiovascular disease (ASCVD) (coronary artery disease (CAD), ischemic stroke, and peripheral artery disease), defined by self-report, ICD-10 codes, or the use of medications for these conditions.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Current Colchicine therapy\n* Hepatic disease\n* Any clinically active diagnosed infection requiring systemic antimicrobial therapy, positive microbiologic evidence of infection, or infection-related hospitalization within 30 days prior to study enrollment.\n* Immunosuppression\n* Current use of chemotherapy drugs or active cancer\n* Pregnancy\u002Fbreastfeeding\n* Hospitalized within the past 6 months\n* Allergic\u002Fintolerance to colchicine\n* Use of P-glycoprotein (p-gp) inhibitor (such as Verapamil, Quinidine, Amiodarone, Ritonavir, Lopinavir\u002Fritonavir, Saquinavir, Nelfinavir)\n* Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (such as Ketoconazole, Itraconazole, Posaconazole, Voriconazole, Clarithromycin, Erythromycin)\n* Human immunodeficiency virus (HIV) infection\n* Gout attack ≥ 1 time per year\n* Severe anemia (hemoglobin \\\u003C 8 g\u002Fdl for women and \\\u003C 9 g\u002Fdl for men)\n* eGFR \\\u003C30 ml\u002Fmin\u002F1.73m2\n* uACR \\\u003C200 mg\u002Fg\n* White blood cell count (WBC) \\\u003C3.0 x109\u002FL\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3 x Upper Limit of Normal (ULN)\n* Total bilirubin \\>2 x ULN\n* Glucose \\>300mg\u002Fdl\n* Uses nicotine products or other recreational drugs\n* Unable to read or speak English\n* Participant in other conflict clinical trial,\n* Unable to complete the study measurements\n* Unable to undergo to computed tomography (CT) or dual-energy X-ray absorptiometry (DXA) scans\n* Unsafe to participate in this study per investigator's judgement.","69 Years",{"count":567,"type":21},60,[58],"The overall objective of this pilot randomized clinical trial is to determine whether low-dose Colchicine (LoDoCo) improves vascular disease including vascular calcification, peripheral arterial disease (PAD), and chronic kidney disease-mineral and bone disorder (CKD-MBD) biomarkers in patients with chronic kidney disease (CKD) stage 3 over a 12-month intervention period, compared with usual care.\n\nSuccessful completion of this study will generate critical preliminary data to support a larger clinical trial aimed at evaluating inflammation-targeted therapies to mitigate CKD-MBD, including vascular calcification and related PAD, as well as osteoporosis, ultimately reducing cardiovascular events and mortality in patients with CKD. Additionally, this work has the potential to redefine the diagnostic framework for CKD-MBD.",[571,91,26,316,572,573],"Chronic Kidney Disease Mineral and Bone Disorder","Atherosclerotic Cardiovascular Disease (ASCVD)","Chronic Kidney Disease (Stage 3)",[195,575,576,577],"CVD","vascular calcification","Colchicine","2026-06-17",{"date":447,"type":36},{"date":116,"type":21},{"date":582,"type":21},"2027-12-31",{"name":584,"class":110},"University of Texas Southwestern Medical Center",{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":591,"eligibilityCriteria":592,"healthyVolunteers":12,"sex":16,"minAge":593,"maxAge":594,"enrollmentInfo":595,"targetDuration":4,"studyType":56,"phases":597,"briefSummary":598,"conditions":599,"keywords":602,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":611},"100536635","safety-and-effectiveness-of-endoscopic-intestinal-re-cellularization-therapy-in-individuals-with-type-ii-diabetes-100536635","NCT06267391","Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes","A Multicenter, Randomized, Double-blind, Sham-controlled Study for Assessing the Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes (ReCET Study)","ReCET","Inclusion Criteria:\n\n* 22- 70 years of age, inclusive.\n* T2D diagnosis for at least 6 months.\n* HbA1C of 7.5-10.5%, inclusive, determined by the central laboratory.\n* BMI 27-40 kg\u002Fm2, inclusive.\n* On 2-4 non-insulin glucose lowering mediations or on monotherapy with either GLP-1 or GLP-1\u002FGIP medications, with no changes in medication or dosing for at least 12 weeks prior to the baseline visit.\n* Individualized metabolic surgery (IMS) score ≤ 95.\n* Weight stability (≤5% weight change) for at least 12 weeks prior to the screening visit.\n* Agree not to donate blood during participation in the study.\n* Able to comply with study requirements and understand and sign the Informed Consent Form.\n* Women of childbearing potential must be not pregnant and using an acceptable method of contraception throughout the study.\n* Willing and able to comply with study visits and study tasks as required per protocol.\n\nExclusion Criteria:\n\n* Diagnosed with type 1 diabetes.\n* History of diabetic ketoacidosis or hyperosmolar nonketotic coma.\n* Fasting serum C-peptide \\\u003C1 ng\u002FmL (333pmol\u002Fl).\n* Current use of insulin, or previous use of any types of insulin for \\>1 month at any time (except for treatment of gestational diabetes) in last 2 years.\n* Hypoglycemic unawareness.\n* History of ≥1 severe hypoglycemia episode in past 6 months\n* Discontinuation of a GLP-1RA or a GLP-1\u002FGIP dual-agonist within 6 months of the screening visit following at least one month of treatment.\n* Known autoimmune disease, including but not limited to, celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder, or as evidenced by a positive anti-glutamic acid decarboxylase (GAD) test.\n* Previous GI surgery that has changed GI anatomy or could limit treatment of the duodenum, such as Billroth 2, Roux-en-Y gastric bypass, gastric band or other similar procedures or conditions.\n* Known history of a structural or functional disorder of the upper GI tract that may impede passage of the device through the upper GI tract or increase risk of tissue damage during an endoscopic procedure, including eosinophilic esophagitis, stricture\u002Fstenosis, varices, diverticula, or other disorder of the esophagus, stomach and duodenum.\n* History of gastroparesis.\n* Acute gastrointestinal illness in the last 7 days.\n* Known history of irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease and Celiac disease.\n* History of chronic or acute pancreatitis.\n* Active hepatitis or active liver disease, or alanine aminotransferase (ALT) level \\>3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory at screening visit. Patients with NAFLD are eligible if their ALT level is ≤3.0 times the ULN.\n* Current use of vitamin K antagonists, such as warfarin, or current use of direct-action oral anticoagulants (DOCAs) that cannot be safely discontinued periprocedurally.\n* Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued for 7 days before the procedure.\n* Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) from treatment through 4 weeks following the procedure. Alternative use of acetaminophen and low dose aspirin is allowed.\n* Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 12 weeks prior to the screening visit.\n* Use of medications known to affect GI motility (e.g. metoclopramide\u002F Reglan)\n* Current use of weight loss medications such as Saxenda \\[liraglutide \\], Xenical® \\[orlistat\\], Acutrim® \\[phenylpropanolamine\\], Sanorex® \\[mazindol\\], Adipex® \\[phentermine\\], BELVIQ® \\[lorcaserin\\], Qsymia® \\[phentermine\u002Ftopiramate combination\\], Contrave® \\[naltrexone\u002Fbupropion\\], or other weight loss medications including over-the-counter \\[OTC\\] medications \\[for example, Allī®\\]) or have discontinued weight loss medications within 6 months.\n* Participation in any structured weight loss program or endoscopic weight loss intervention within 6 months of the screen visit.\n* Persistent anemia, defined as hemoglobin \\\u003C10 g\u002FdL.\n* Known history of hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.\n* History of blood donation or transfusion within 3 months prior to the Screening Visit.\n* Unstable or paroxysmal cardiac arrhythmia.\n* Any of the following cardiovascular conditions within 6-months prior to screening visit: acute myocardial infarction, cerebrovascular accident (stroke), hospitalization due to congestive heart failure.\n* History of valvular heart disease or chronic heart failure (NYHA III or IV).\n* Estimated glomerular filtration rate (eGFR) ≤ 45 ml\u002Fmin\u002F1.73m2 calculated by CKD-EPI Creatinine Equation as determined by the central laboratory.\n* Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the participant a poor candidate for clinical trial participation in the opinion of the investigator.\n* History of secondary hypothyroidism or inadequately controlled primary hypothyroidism (TSH value outside the normal range at screening).\n* Presence of any implanted electronic devices that cannot be turned off during the procedure\n* Presence of duodenal or biliary stents.\n* Not a candidate for upper GI endoscopy or general anesthesia.\n* Active illicit substance abuse or alcoholism (\\>2 drinks\u002Fday regularly).\n* Active malignancy within the last 5 years (excluding non-melanoma skin cancers).\n* Women who are breastfeeding.\n* Participating in another ongoing clinical trial of an investigational drug or device.\n* Binge eating disorder, or any other mental or physical condition which, in the opinion of the study investigator, makes the participant a poor candidate for clinical trial participation.\n* Critically ill or has a life expectancy \\\u003C5 years.\n* Are investigator site personnel directly affiliated with this study and\u002For their immediate family member. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.","22 Years","70 Years",{"count":596,"type":21},264,[88],"This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications.",[600,601,405,26,532],"Type 2 Diabetes Mellitus","Type2diabetes",[26,532,603],"Duodenal Mucosal Resurfacing",{"date":447,"type":36},{"date":606,"type":36},"2024-05-01",{"date":608,"type":21},"2026-10-01",{"name":610,"class":181},"Endogenex, Inc.",45,{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":4,"eligibilityCriteria":618,"healthyVolunteers":140,"sex":16,"minAge":52,"maxAge":18,"enrollmentInfo":619,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":620,"conditions":621,"keywords":622,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":626,"startDateStruct":627,"completionDateStruct":4,"leadSponsor":629,"locationsCount":44},"100063220","urinary-vitamin-c-loss-in-diabetic-subjects-100063220","NCT00071526","Urinary Vitamin C Loss in Diabetic Subjects","Urinary Vitamin C Loss in Subjects With and Without Diabetes","* INCLUSION CRITERIA:\n\nTo be included in the study, study subjects should be:\n\n* Aged 18-65 years.\n* Either:\n\n  * Have no diagnosis of diabetes: \"nondiabetic controls\", or\n  * Have a diagnosis in their medical history of either Type 1 or Type 2 diabetes\n\nEXCLUSION CRITERIA (for outpatient study, arm 1)\n\nExclusion criteria will include the following:\n\n* Unable or unwilling to provide a signed and dated informed consent form\n* Unable or unwilling to comply with study procedures and lifestyle considerations\n\nEXCLUSION CRITERIA (for inpatient studies, arms 2 and 3)\n\nStudy participants interested in participating in Arms 2 and\u002For 3 will be excluded from this further participation if they meet any of the following:\n\n* significant organ malfunction leading to clinical instability including liver disease, pulmonary disease, ischemic heart disease, heart failure, stroke, peripheral vascular disease, and anemia at investigator discretion\n* other serious or chronic illness; history of serious or chronic illness; coronary artery disease, or peripheral vascular disease resulting in clinical instability\n* pregnancy or lactation\n* presence of other conditions which, in the judgment of the investigators, can influence vitamin C metabolism or vitamin C renal handling",{"count":264,"type":21},"Several studies have reported that diabetic subjects have lower plasma vitamin C concentrations than non-diabetic subjects. Although urinary vitamin C loss in diabetic subjects was reported to be increased in two studies, these are difficult to interpret due to lack of controlled vitamin C intake, inadequate sampling, lack of control subjects, or methodology uncertainties in vitamin C assay and sample processing. Consequently, it is unclear whether diabetic subjects truly have both low plasma and high urine vitamin C concentrations. We propose that low plasma vitamin C concentrations in diabetic subjects are due in part to inappropriate renal loss of vitamin C in these subjects but not in healthy controls. We will study nondiabetic controls and cohorts with diabetes. Vitamin C concentrations in plasma, RBCs, and urine will be measured in outpatients. In those willing to be admitted to the Clinical Center, we will measure vitamin C pharmacokinetics to determine the relative bioavailability for vitamin C in individuals with and without abnormal urinary loss of vitamin C (or renal leak). Single nucleotide polymorphisms (SNPs) will be determined in genomic DNA responsible for the two proteins mediating sodium dependent vitamin C transport, SVCT1 and SVCT2. We will also explore mechanisms underlying abnormal urinary vitamin C loss....",[26],[623,168,624,625,64],"Renal Threshold","Proteinuria","Plasma Concentrations",{"date":513,"type":36},{"date":628,"type":36},"2006-04-11",{"name":42,"class":43},{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":140,"sex":16,"minAge":52,"maxAge":594,"enrollmentInfo":636,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":637,"conditions":638,"keywords":639,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":643,"startDateStruct":644,"completionDateStruct":4,"leadSponsor":646,"locationsCount":44},"100054784","diabetes-and-heart-disease-risk-in-blacks-100054784","NCT00001853","Diabetes and Heart Disease Risk in Blacks","* IINCLUSION AND EXCLUSION CRITERIA\n\nCRITERIA FOR INCLUSION:\n\nEthnicity: Black\n\nThis is a study of adult African Americans and Blacks that were born in Africa but are now living in the United States. As African American people are multi-ethnic, we will in this initial investigation, study two different groups of African American. To enroll participants must self-identify as African Americans and be born in the United States, with American born parents or be born in Africa with African born parents. In both groups we will study sex differences in the role of obesity and TG levels on cardiovascular disease. In the future, we plan to expand the study to include other groups which self-identify as African Americans (i.e.AfroCarribeans and Hispanic blacks).\n\nOnly blacks are included in this study because the focus of this study is on gender differences in blacks in risk factors for CAD, specifically obesity, TG levels and TG related CAD risk factors. Unlike Caucasian women, premenopausal black women do not appear to be as protected from heart disease as a result of their gender. One model to study this apparent decrease in gender\n\nrelated cardioprotection in black women is to compare black men to black women. An alternative model would be to compare black women to Caucasian women. However, since the primary focus of this work is on gender differences rather than racial differences comparing black women to men is a superior model. Other racial groups do not share the loss of gender-related cardioprotection found in blacks, and have been excluded. Further the advantage of comparing black men and women is that this comparison provides a better control of dietary, cultural and genetic factors.\n\nAge: The age range of the participants will be between 18 and 70 years. As stated in the original protocol on page 14: Future investigations are planned which will involve similar comparisons between premenopausal and postmenopausal black women and between whites and blacks. To investigate risk for glucose intolerance, diabetes and cardiovascular risk factors, it is no longer sufficient to maintain the age range between 18 and 50 years. We need to expand to an age range with an increased prevalence of these risk factors.\n\nMedical History: To participate in the study subjects should identify themselves as healthy. This is important so the broadest possible sample of people will enroll. The fact that people are healthy will be confirmed by the history, physical and laboratory tests done as part of the screening visit. People with established coronary artery as evidenced by history of myocardial infarction, coronary artery bypass surgery or PTCA will be allowed to participate if they are not currently having angina.\n\nCRITERIA FOR EXCLUSION:\n\nBlack Ethnicity other than American or African.\n\nAs stated in the inclusion criteria black people are a multi-ethnic group. In this initial investigation we are focusing on African Americans who are American born and Africans living in the United States who are African born. In the future, we will expand the study to include other groups of blacks such as individuals of Afro-Caribbean and Hispanic blacks.\n\nMedications: People who take medications that are known to alter the parameters which are under investigation in this study will be excluded. People taking medications to treat hyperlipidemia will be included but analyses will be adjusted to take this into account. Subjects on thyroid hormone replacement will be included if their TSH is normal.\n\nDiabetes: Because diabetes affects insulin sensitivity and TG levels all people with diabetes even if the diabetes is controlled with diet alone will not be enrolled in the study.\n\nPregnant or Breastfeeding: Women who are pregnant, breastfeeding, or have an infant that is less than four months of age will be excluded. This is because the physiologic changes associated with pregnancy, breastfeeding or recent childbirth affect the parameters under study.\n\nMenstrual History: Now that postmenopausal women are included, menstrual history will be taken but women with irregular menses and hysterectomy will not be excluded. Women between the ages of 40 and 55 years will have FSH checked for proper characterization. Women 56 years of age and older will be assumed to be postmenopausal. However, women on any type of injectable hormonal contraception will be excluded because hormonal contraception affects both TG levels and glucose metabolism.",{"count":191,"type":21},"It is unknown if obesity contributes to the development of heart disease in African American men and women.\n\nThis study was created to determine whether there is a relationship between sex and body size and the incidence of heart disease in African American men and women. Researchers will attempt to associate obesity with the presence of heart disease risk factors. Risk factors that will be studied include; total body fat, body fat distribution, fat content of the blood (triglyceride concentration, low density lipoproteins \\[LDL\\], and high density lipoproteins \\[HDL\\]), how fast fat is removed from the blood, and how well insulin works in the body.\n\nScientific studies have shown that obesity and increased levels of fat content in the blood are important risk factors for heart disease in Caucasian women. However, similar studies in African American women have failed to show the same correlation. In fact, it appears that African American women in all three body weight groupings, nonobese, overweight, and obese experience high death rates due to heart disease. In addition, prior research has shown that obese African American men tend to have elevated levels of fat in the blood while African American women have normal blood fat levels. Therefore, if high levels of triglycerides (fat found in the blood) are not seen in non-diabetic obese African American women, it cannot be considered a risk factor in this population. This suggests that studies conducted on Caucasian women may not provide insight into heart disease risk factors in African American women.\n\nThe study will take 2000 healthy non-diabetic African American men and women (ages 18-70) and body mass index 3 subgroups; nonobese, overweight and obese. Diabetes undeniably increases the risk of heart disease. Therefore patients suffering from diabetes will not be included in the study. Candidates for the study will undergo a series of tests and examinations over 2 outpatient visits. Subjects will have body fat analyses, resting energy expenditure measurements, an EKG (electrocardiogram), and specific blood tests.\n\nResearchers believe this study will provide significant insight into the causes of obesity and heart disease in African Americans.",[320,26,25,91],[640,641,26,642,147],"Healthy Volunteers","Health Disparities","Cardiovascular Disease",{"date":513,"type":36},{"date":645,"type":36},"1998-10-21",{"name":42,"class":43}]