[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"type2diabetes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:type2diabetes":296},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,34,0,25,[9,46,78,111,136,164,192,226,254,282,306,331,360,386,417,455,480,501,528,549,573,594,624,650,674],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100512089","real-time-continuous-glucose-monitoring-system-in-t2dm-with-pregnacy-100512089",false,"NCT05947916","Real Time Continuous Glucose Monitoring System in T2DM With Pregnacy","Effect of Real Time Continuous Glucose Monitoring System on Management of Women With Type 2 Diabetes Mellitus During Pregnancy in a Multidisciplinary Comprehensive System","Inclusion Criteria:\n\n* A clear history of type 2 diabetes, or a history of type 2 diabetes diagnosed in early pregnancy\n* Singleton gestation at 4-26 weeks, with substandard glycemic control (i.e., fasting glucose \\> 5.3 mmol\u002FL, and or 1 hour postprandial glucose \\> 7.8 mmol\u002FL, and or 2 hours postprandial glucose \\> 6.7 mmol\u002FL) after lifestyle intervention ± basal insulin therapy, as assessed by the endocrinology department. Patients who need insulin regimen with basal plus meal or insulin pump regimen.\n* Patients are willing and committed to establish and follow up in the obstetrics and gynecology departments of Peking University Third Hospital, Haidian District Hospital and Yanqing District Hospital during pregnancy, and are willing to provide information on obstetric examination and perinatal medical records if they are transferred to the hospital for special reasons for follow-up or delivery.\n* Voluntarily participate in the study, examine and follow up according to this project and sign informed consent.\n* Able to pass the screening period Adherence evaluation\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes, specific type of diabetes or gestational diabetes\n* Pregnancy with severe comorbidities or diabetic complications for which obstetrics does not recommend continuation of pregnancy, including but not limited to the following: proliferative retinopathy, chronic kidney disease (eGFR less than 60 mL\u002Fmin\u002F1.73± massive proteinuria), known coronary and cerebrovascular disease, autoimmune system disease and receiving exogenous glucocorticoids or immunosuppressive therapy.\n* Patients who have been hospitalized for psychiatric treatment within 6 months prior to enrollment or are still on psychiatric medications.\n* Patients who have received other interventional studies.","FEMALE","18 Years","40 Years",{"count":21,"type":22},240,"ESTIMATED","INTERVENTIONAL",[25],"NA","The prevalence of type 2 diabetes mellitus (T2DM) in women of childbearing age is increasing rapidly, and low glucose compliance leads to an increased risk of adverse pregnancy outcomes for mothers and infants during pregnancy in women with T2DM. Real-time continuous glucose monitoring (CGM) is an important tool for glucose monitoring and patient education, as it can continuously record blood glucose throughout the day and provide real-time feedback on high and low blood glucose levels. This is a multicenter, open-label, randomized controlled clinical study to investigate the efficacy, safety, and maternal and infant pregnancy outcomes of using real-time CGM monitoring compared with conventional self-monitoring of blood glucose (SMBG) on the basis of multidisciplinary management in pregnant women with T2DM. One hundred and twenty pregnant women with T2DM in early pregnancy who were enrolled in intensive insulin therapy were randomly divided into the real-time CGM group and the conventional SMBG group. The real-time CGM intervention group wore real-time CGM for more than 50% of the pregnancy in addition to regular SMBG; the control group only performed regular SMBG. Both groups wore Medtronic iPro 2 for 3 days in early, mid and late pregnancy, and the time in the target range of blood glucose (TIR) was recorded in a blinded manner. Primary outcome: differences in TIR between the two groups of pregnant women in early, mid, and late pregnancy. Secondary outcomes included differences in glycated hemoglobin, hypoglycemia, insulin dose before delivery, pregnancy weight gain, and maternal and infant pregnancy outcomes.",[28,29,30,31,32],"Type2diabetes","Pregnancy Related","Continuous Glucose Monitoring","Time in Range","Pregnancy Outcome","RECRUITING","2026-06-30",{"date":36,"type":37},"2026-07-02","ACTUAL",{"date":39,"type":37},"2024-01-30",{"date":41,"type":22},"2026-12-31",{"name":43,"class":44},"Peking University Third Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":45},"100490156","successfully-achieving-and-maintaining-euglycemia-during-pregnancy-for-type-2-diabetes-through-technology-and-coaching-100490156","NCT05662462","Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching","ACHIEVE: Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching","Inclusion Criteria:\n\n1. pregnant individuals age ≥18 years;\n2. ≤20 weeks of gestation (specifically, \\\u003C20+6 weeks);\n3. diagnosis of pregestational T2D and A1c ≥6.5% at the time of study enrollment;\n4. Medicaid insurance;\n5. English or Spanish speaking;\n6. cognitively able to complete the study requirements;\n7. consent to all study activities;\n8. accessible for participation in study activities;\n9. use a smartphone with internet access;\n\nParticipants must also consent to the study team abstracting information from their electronic health records (EHRs), using CGM for glucose monitoring if randomized to the intervention group, tracking the participants' clinic, hospital, and emergency room visits during the study period, as well as tracking the number of times the participants use the ACHIEVE mobile health (mHealth) application (app), including what activities are used in the mobile application (e.g., recording blood glucose, scheduling appointments, messaging their healthcare providers, accessing educational resources).",{"count":54,"type":22},124,[25],"The ACHIEVE RCT will measure the effect of the intervention (mHealth app with CGM, provider dashboard, and care team coaching) compared to current standard care (prenatal visits, self-monitored blood glucose, and certified diabetes care and education specialist) on achieving glycemic control (hemoglobin A1c \\\u003C6.5% in the third trimester). We hypothesize a 25% absolute increase in the proportion of participants in the intervention group who will meet the target hemoglobin A1c \\\u003C6.5% in the third trimester compared to the standard care group",[58,28,59,60],"Pre-Gestational Diabetes","Pregnancy in Diabetic","Pregnancy, High Risk",[62,63,64,65,66,67,68],"mHealth","Pregnancy","Type 2 diabetes","Continuous glucose monitoring","Mobile application","Medicaid","Glycemic control","2026-06-24",{"date":71,"type":37},"2026-06-29",{"date":73,"type":37},"2024-07-11",{"date":75,"type":22},"2029-03",{"name":77,"class":44},"Ohio State University",{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":92,"conditions":93,"keywords":98,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":110},"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.","ALL","22 Years","70 Years",{"count":90,"type":22},264,[25],"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.",[94,28,95,96,97],"Type 2 Diabetes Mellitus","Diabetes Mellitus, Type 2","Diabetes","Type 2 Diabetes",[96,97,99],"Duodenal Mucosal Resurfacing","2026-06-17",{"date":102,"type":37},"2026-06-22",{"date":104,"type":37},"2024-05-01",{"date":106,"type":22},"2026-10-01",{"name":108,"class":109},"Endogenex, Inc.","INDUSTRY",45,{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":86,"minAge":18,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":121,"conditions":122,"keywords":123,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":45},"100629287","integrating-a-prescription-produce-program-within-a-diabetes-prevention-program-100629287","NCT07472712","Integrating a Prescription Produce Program Within a Diabetes Prevention Program","Integrating a Prescription Produce Program Within a Diabetes Prevention Program to Address Health Inequities Among Adults","Inclusion Criteria:\n\n* ≥age 18\n* rationale: adolescents who are at-risk of T2DM may have unique needs that will not be addressed in this study\n* Most recent BMI ≥ 25kg\u002Fm 2 and not pregnant\n* rationale: elevated BMI is associated with higher risk of developing T2DM\n* Elevated glucose as evidenced by one of the following criteria:\n* Hemoglobin A1c 5.7-6.4% indicative of prediabetes within the last 36 months\n* Fasting blood glucose 100-125mg\u002Fdl or 2-hour glucose 140-199mg\u002Fdl within the last six months\n* Physician diagnosis of prediabetes (impaired fasting glucose, impaired glucose intolerance)\n* These criteria indicate the presence of prediabetes and places individuals are risk of T2DM\n* Speak, read, and understand English\n* rationale: current version of PPP intervention (cooking classes) is available in English\n* Have a working U.S.- based phone number\n* rationale: participants must have a working phone number because they will receive automated text messages as reminders to receive session reminders; participants must have a working phone number in case adverse event monitoring contacts are required\n* Able to attend study-related sessions at the Health Hub @ 25th over the year long study (i.e., weekly for 4 months, then monthly for 7 months)\n* rationale: participants must be able to attend study activities at the community site in order to engage in the intervention and study related sessions.\n\nExclusion Criteria:\n\n* Individuals with HbA1c or glucose levels above the indicated glucose ranges will be advised to see their physician and excluded from participation unless they receive physician consent to participate.\n* Pregnant adults (\\>18 years old) will not be included in this current study because prediabetes (HbA1c levels between 5.7% - 6.4% within the last 36 months) during pregnancy presents unique physiological challenges that the study intervention does not address.\n* Pregnancy status will be based on participants self-report. We will not provide any pregnancy tests prior to enrollment.",{"count":119,"type":22},100,[25],"Type 2 Diabetes remains a major chronic disease among adults in the United States. A way to prevent Type 2 Diabetes is to engage in a diabetes prevention program. In the diabetes prevention program, individuals at risk of Type 2 Diabetes meet with a health coach to learn effective ways to build health behaviors around diet and physical activity. Individuals who participate in the diabetes prevention program are more likely to lose weight and eat a healthy diet.",[28],[124,125,126],"Health Coach","Food Insecurity","Prevention Program","2026-06-03",{"date":129,"type":37},"2026-06-05",{"date":131,"type":37},"2026-05-26",{"date":133,"type":22},"2028-05",{"name":135,"class":44},"Virginia Commonwealth University",{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":86,"minAge":143,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":146,"briefSummary":147,"conditions":148,"keywords":152,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":45},"100552157","the-impact-of-geriatric-assessment-on-the-treatment-plan-of-elderly-patients-with-t2dm-100552157","NCT06469437","The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With T2DM","The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With Type 2 Diabetes Mellitus: a Randomized Clinical Trial.","Inclusion Criteria:\n\n* Age 60 years or older\n* Diagnostic of type 2 diabetes mellitus according to American Diabetes Association criteria\n* Patients under follow-up in a specialized endocrinology outpatient clinic\n* Patients who have a glycated hemoglobin measurement of up to three months\n\nExclusion Criteria:\n\n* Lack of consent for research participation from the patient or the physician\n* Patients classified as Clinical Frailty Scale 9.","60 Years",{"count":145,"type":22},220,[25],"Introduction: With the aging of the world population and the increasing incidence of type 2 diabetes mellitus (T2DM) with age, the number of elderly individuals living with diabetes has been considerably rising. It is known that uncontrolled T2DM negatively impacts various health outcomes, including geriatric outcomes such as sarcopenia, frailty, immobility, incontinence, and infections. Current medical literature fails to establish appropriate glycemic targets for different elderly profiles. Although guidelines emphasize the need to individualize targets, there is no concise tool to identify which individuals benefit from each therapeutic approach. Data suggest that frailty is the best predictor of negative outcomes in elderly patients living with T2DM. The Clinical Frailty Scale (CFS) and the 10-minute Targeted Geriatric Assessment (TaGA-10) are validated tools for prognosis in elderly patients and for identifying frail elderly individuals.\n\nMethods: Randomized controlled trial. Elderly individuals diagnosed with T2DM at a tertiary care outpatient clinic will be included. All enrolled patients will undergo geriatric assessment using CFS, TaGA-10, and Charlson Comorbidity Index. Patients will be randomized into usual care and intervention groups, and the intervention involves providing the geriatric assessment to the care team to support their decisions. The adequacy of the therapeutic approach will be measured in one week by reviewing the consult record or interviewing the physician. The clinical impact on the frequency of hypoglycemia, falls, infections, hospitalizations, and mortality will be evaluated at 3 and 6 months by telephone interviews.\n\nDiscussion: Current guidelines recommend using age, comorbidities, cognitive, and functional status to individualize therapeutic targets in elderly patients with T2DM; however, it is possible that these variables alone may not be sufficient to classify all elderly individuals in their complexity adequately. A tool with such power and easy to use in clinical practice is necessary.",[28,149,150,151],"Frail Elderly Syndrome","Frailty","Geriatric Assessment",[64,150,153,154],"Geriatric assessement","Glycated hemoglobin","2026-05-27",{"date":157,"type":37},"2026-05-29",{"date":159,"type":37},"2024-07-05",{"date":161,"type":22},"2028-12-31",{"name":163,"class":44},"Hospital de Clinicas de Porto Alegre",{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":86,"minAge":170,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":23,"phases":174,"briefSummary":176,"conditions":177,"keywords":178,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":45},"100477648","phase-2-the-effects-of-glucagon-on-hepatic-metabolism-in-people-with-type-2-diabetes-after-caloric-restriction-100477648","NCT05499702","The Effects of Glucagon on Hepatic Metabolism in People With Type 2 Diabetes After Caloric Restriction","Inclusion Criteria:\n\n* We will recruit up to 20 weight-stable, subjects with type 2 diabetes\n* BMI ≥ 28 Kg\u002FM2\n* Diabetes is managed by diet alone or a combination of oral agents\n\nExclusion Criteria:\n\n* History of prior upper abdominal surgery e.g. gastric banding, pyloroplasty, vagotomy.\n* Active systemic illness or malignancy.\n* Symptomatic macrovascular or microvascular disease.\n* Contraindications to MRI (e.g. metal implants, claustrophobia).\n* Hematocrit \\\u003C 35%\n* TSH \\\u003C 0.4 or \\> 5.5.\n* Consumption of \\> 2 alcohol drinks per day or \\> 14 per week or a positive AUDIT questionnaire.","25 Years","65 Years",{"count":173,"type":22},20,[175],"PHASE2","Caloric restriction (and RYGB) improves insulin action and lowers fasting glucose, glucagon and EGP, without changes in postprandial EGP and glucagon concentrations. Caloric restriction also improves hepatic steatosis and lowers fasting AA. These changes may represent restoration of glucagon's hepatic actions. This experiment will determine whether caloric restriction improves glucagon's actions on hepatic amino acid, carbohydrate and lipid metabolism in T2DM in comparison to a baseline experiment performed separately in people with T2DM.",[28],[179,180,181,182,183],"glucagon","insulin resistance","caloric restriction","hepatic steatosis","amino acid metabolism",{"date":185,"type":37},"2026-05-28",{"date":187,"type":37},"2022-12-15",{"date":189,"type":22},"2027-12-31",{"name":191,"class":44},"Adrian Vella",{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":86,"minAge":18,"maxAge":4,"enrollmentInfo":199,"targetDuration":201,"studyType":202,"phases":4,"briefSummary":203,"conditions":204,"keywords":209,"overallStatus":217,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":4},"100637631","cgm-experience-preferences--blood-glucose-parameters-100637631","NCT07607015","CGM Experience, Preferences & Blood Glucose Parameters","Instara™-1 Dual Perspectives on Continuous Glucose Monitoring: Understanding Patient Experience and Healthcare Professional Preferences","Inclusion Criteria:\n\n* Subjects to provide written informed consent prior to any study procedures being performed\n* Subjects with age 18 and above both male and female\n* Diagnosed with Diabetes Miletus Type I, Type II and\u002For GDM\n* Comfortable using smart phone, access to internet along with Bluetooth connectivity throughout the study duration.\n* Subjects (Patients) on oral or injectable anti-diabetic medications, (in case of insulin, patient must be on insulin from last 3 months )\n* Subjects (HCPs) healthy, Pre-diabetes or Diabetes Miletus (any type)\n\nExclusion Criteria:\n\n* History of hypersensitivity to any of the active or inactive ingredients of the CGM device used in the trial, and\u002For history of significant allergic skin reactions.\n* Presence of severe diabetes complications e.g. retinopathy, acute metabolic crisis, etc.\n* History of active\u002F acute renal and\u002For hepatic failure.\n* Patients who have been admitted to the hospital in the past 3 months for diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.\n* History of critical illness or incapacitated patients\n* History of acute psychiatric disorder or exacerbation of chronic psychiatric disorder.\n* History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study.\n* Medical conditions that require patients to undergo frequent radiation\u002F imaging procedures for example CT, MRI and X rays\n* History of known hematological disorders such as Sickle Cell Disease \\& Trait, Thalassemia, Hemolytic Anemias (e.g., G6PD deficiency, autoimmune), Iron Deficiency Anemia\n* Patients on high doses of acetaminophen (\\>1 gram every 6 hours), ascorbic acid supplements (e.g., \\> 500-1000 mg\u002Fday), IV sorbitol, steroids and aspirin which can alter the readings on the CGM device.",{"count":200,"type":22},75,"3 Months","OBSERVATIONAL","This is an open-label, prospective, multicenter observational study designed to evaluate the perceived benefits, device experience, preference, and glucose-related parameters associated with the Instara-1 Continuous Glucose Monitoring device. The study will include patients with diabetes and healthcare professionals. Patients will use Instara- 1 and will be followed up to assess device experience, glucose parameters, and diabetes-related quality of life. Healthcare professionals will evaluate device experience and preference, including comparison with FreeStyle Libre 2.",[205,28,206,207,208],"Diabete Mellitus","type1diabetes","Gestational Diabetes","Pre Diabetes",[210,211,212,213,214,215,216],"CGM","Glucose monitoring","Time in range","estimated HbA1c","Time above range","Time below range","Diabetes Quality of life","NOT_YET_RECRUITING","2026-05-19",{"date":131,"type":37},{"date":221,"type":22},"2026-09-10",{"date":223,"type":22},"2027-08-10",{"name":225,"class":109},"Getz Pharma",{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":86,"minAge":232,"maxAge":233,"enrollmentInfo":234,"targetDuration":4,"studyType":23,"phases":235,"briefSummary":236,"conditions":237,"keywords":240,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":45},"100624989","feasibility-and-adherence-to-a-technology-assisted-home-based-strength-training-program-in-adults-with-type-2-diabetes-mellitus-and-mild-cognitive-impairment-100624989","NCT07416799","Feasibility and Adherence to a Technology-assisted Home-based Strength Training Program in Adults With Type 2 Diabetes Mellitus and Mild Cognitive Impairment","Inclusion Criteria:\n\n1. Age: 55-80 years\n2. Diabetes: Diagnosed T2DM with ≥5 years duration\n3. Cognitive Status: Mild cognitive impairment as defined by Petersen criteria and confirmed by Montreal Cognitive Assessment (MoCA) scores of 18-25\n4. Medication Stability: Stable medication regimen for at least 3 months\n5. Physical Capability: Physically capable of participating in moderate-intensity exercise (physician clearance required)\n6. Support System: Having a caregiver or support person willing to assist with technology use if needed\n\nExclusion Criteria:\n\n1. Diagnosis of movement disorders such as multiple sclerosis, parkinson's disease\n2. Diagnosis of Alzheimer's disease,\n3. Current diagnosis of severe depression, major psychiatric conditions such as bipolar disorder, psychosis, schizophrenia, or alcoholism that could affect the ability to understand and\u002For cooperate fully with the protocol.\n4. Significant cerebral vascular disease\n5. Concomitant medications with significant cholinergic or anticholinergic effects or adverse effects on cognition, including antipsychotics, tricyclic antidepressants, anticonvulsants, sedative\u002Fhypnotics, anxiolytics, glucocorticoids (chronic or frequent intermittent),\n6. Visual\u002Fhearing impairment that would significantly impact the ability to participate in psychometric testing.\n7. Significant medical illness or organ failure, including hepatic or renal failure, unstable cardiac disease,\n8. Untreated B12 deficiency or hypothyroidism (stable treatment for at least 3 months is allowable).\n9. Uncontrolled hypertension: over 160 mmHg systolic or 100 mmHg diastolic (stable treatment is allowable).\n10. Stage 5 renal impairment (GFR less than 15 or dialysis).\n11. Participation in another clinical trial.\n12. Prisoners.\n13. Exercise Contraindications: Any condition that would make moderate-intensity exercise unsafe such as a history of severe aortic stenosis, poorly controlled hypertension, angina, or syncope.\n14. Lack of Support: No available caregiver or support person for technology assistance","55 Years","80 Years",{"count":173,"type":22},[25],"This is a single-arm feasibility study employing a pre-post design with a 12-week intervention period. The study utilizes a telehealth-assisted home-based resistance exercise program, with a structured progression from supervised to unsupervised sessions over 12 weeks.",[28,238,239],"Mild Cognitive Impairment","Age-related Cognitive Decline",[241,242,243,244],"Home-Based exercise","Type 2 Diabetes Mellitus (T2DM)","Mild cognitive impairment (MCI)","Ages 55-80","2026-05-07",{"date":247,"type":37},"2026-05-11",{"date":249,"type":37},"2026-04-14",{"date":251,"type":22},"2027-03",{"name":253,"class":44},"The University of Texas Medical Branch, Galveston",{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":86,"minAge":262,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":266,"conditions":267,"keywords":269,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":45},"100497609","phase-2-nad-augmentation-in-diabetes-kidney-disease-100497609","NCT05759468","NAD Augmentation in Diabetes Kidney Disease","NAD Augmentation to Treat Diabetes Kidney Disease: A Randomized Controlled Trial","DKD","Inclusion Criteria:\n\n1. A man or a postmenopausal woman (complete cessation of menses for one or more years and \u002For FSH \\> 20 U\u002FL), 30 years or older\n2. Has type 1 or type 2 diabetes mellitus, as indicated by any of the following:\n\n   1. Self-report of type 1 or type 2 diabetes plus the use of a prescribed medication.\n   2. ICD-10 code for type 1 or type 2 diabetes plus current use of a medication in the electronic medical record.\n   3. HbA1c \\>6.4%; or 2 fasting glucose \\> 125 mg\u002FdL\n3. Has an average of two or more morning UACR equal to or above 100mg\u002Fg creatinine each of which must be equal to or greater than 60 mg \u002F g creatinine with at least one UACR value measured during the screening visit.\n\n   a. Recent UACR value in the medical record within the preceding 3 months prior to screening is acceptable.\n4. If type 2 diabetic and UACR is \\> 300 mg\u002Fg creatinine, must be currently using an ACE inhibitor or an ARB or a SGLT2 inhibitor.\n5. eGFR \\> 25 mL\u002F min \u002F 1.73 m2\n6. Hemoglobin A1c \\\u003C10%\n7. Able to speak English or Spanish or Haitian Creole\n8. Willing and able to provide written informed consent\n9. In addition, female participants must Not be pregnant and not planning to become pregnant over the next 6 months.\n\nExclusion criteria:\n\n1. Fasting morning UACR \\> 5,000 mg\u002F g creatinine\n2. Other laboratory abnormalities:\n\n   1. Has AST or ALT \\> 3 times the upper limit of normal\n   2. eGFR \\\u003C 25 mL\u002F min \u002F 1.73 m2\n   3. Hematocrit \\\u003C 0.34 or \\> 0.50 L\u002FL\n3. A major adverse cardiovascular event in preceding 3 months\n4. Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter\n5. Current alcohol or substance use disorder or dependence (DSM 5 criteria).\n6. Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures.\n7. An acute illness, including COVID-19, requiring hospitalization within the past 3 months or any acute illness, including COVID-19, within the past month.\n8. Has a history of anaphylaxis from vitamin B3 derivatives\n9. BMI \\> 42.5 kg\u002F m2\n10. If patient has a confirmed diagnosis of type 3 diabetes, or gestational diabetes.","30 Years",{"count":264,"type":22},156,[175],"A phase 2a trial randomized, double-blind, placebo-controlled, parallel group trial to determine whether NMN administration improves DKD, as indicated by a significantly greater reduction in UACR compared with placebo administration. Eligible participants will be randomized to receive either 1000 mg NMN or placebo twice daily.",[28,268],"Diabetic Kidney Disease",[270,271,272],"diabetes","type 2 diabetes","kidney disease","2026-04-08",{"date":275,"type":37},"2026-04-13",{"date":277,"type":37},"2023-04-13",{"date":279,"type":22},"2027-03-31",{"name":281,"class":44},"Brigham and Women's Hospital",{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":86,"minAge":19,"maxAge":233,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":292,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":305},"100469291","phase-4-prevention-of-cardiovascular-and-diabetic-kidney-disease-in-type-2-diabetes-100469291","NCT05390892","PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes","PRECIDENTD: PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes","PRECIDENTD","Inclusion Criteria:\n\n* Type 2 diabetes based on clinical diagnosis\n* HbA1c ≥6% measured within 12 months prior to screening\n* Secondary prevention cohort (at least 70% of cohort):\n\n  * Age 40 to 80 years\n  * Evidence of established atherosclerotic cardiovascular disease (ASCVD), as defined by one or more of the following\n  * Coronary heart disease defined by at least one of the following: prior myocardial infarction, prior coronary percutaneous coronary intervention, ≥50% stenosis of a coronary artery documented by invasive or non-invasive imaging (including CT coronary angiography), positive stress test, or coronary artery calcium score \\>400 Agatston units;\n  * Cerebrovascular disease defined by at least one of the following: prior ischemic stroke, prior carotid revascularization procedure, carotid stenosis ≥ 50% documented by X-ray angiography, MR angiography, CT angiography, or Doppler ultrasound;\n  * Symptomatic peripheral artery disease defined by at least one of the following: leg symptoms with an ABI ≤ 0.9, leg symptoms with imaging evidence of a stenosis ≥50% in a peripheral artery documented by X-ray angiography, MR angiography, CT angiography, or Doppler ultrasound, or prior amputation for atherosclerotic disease.\n* Primary prevention cohort (capped at 30% of cohort):\n\n  * Age 60-80 years and at least 1 additional high-risk feature:\n  * Cardiovascular risk factors\u002Fhigh-risk features:\n  * Active smoking (combustible tobacco or marijuana)\n  * HbA1c ≥ 8% measured within 12 months prior to screening. The most recent value available at the time of screening will be used for screening and to determine eligibility.\n  * Stage 3a CKD, eGFR 45-59 ml\u002Fmin\u002F1.73m2 measured within 12 months prior to screening. The most recent value available at screening will be used for screening and to determine eligibility.\n* Willingness to be randomly assigned to medication class (SGLT2i or GLP-1 RA or both) and fill prescription through personal pharmacy benefit while having other medications adjusted for safety\n* Willingness to avoid starting a therapy in the alternative treatment group (e.g., if randomized to GLP-1 RA, avoid starting an SGLT2i) unless strongly recommended by the participant's usual care provider.\n* If taking one of the study medication classes, willingness to stop SGLT2i or GLP-1 RA and be randomly assigned to one of the two medication classes\n* Willingness to consent to data collection using the electronic health record and sign a medical release to obtain future medical records from other health care facilities\n\nExclusion Criteria:\n\n* Known or suspected diabetes of other cause (type 1 diabetes, pancreatogenic diabetes, monogenic diabetes, etc.)\n* Any background diabetes medication regimen will be allowed in this pragmatic trial with the following proviso:\n\n  o Participants taking basal-bolus, prandial, or multiple daily injection insulin (MDI) regimens (e.g., short-acting in combination with long-acting insulin, called MDI regimens) are eligible only if the research staff attests that there has been communication with the usual diabetes care provider and that the provider has agreed to manage insulin adjustment with initiation of study medications. If such agreement has not been obtained, participants taking MDI regimens are excluded.\n* History of diabetic ketoacidosis\n* Active diabetic foot ulcer\n* History of pancreatitis\n* Heart failure as a primary reason for hospitalization within the past year\n* Known left ventricular ejection fraction \\\u003C40%\n* Known urinary albumin-to-creatinine ratio \\>200 mg\u002Fg at screening\n* Estimated glomerular filtration rate (eGFR) less than 45 ml\u002Fmin\u002F1.73m2 measured within 12 months prior to screening. The most recent value available at screening will be used for screening and to determine eligibility.\n* Known inability to afford study medication through current insurance coverage.\n* If a woman of child-bearing potential, the patient or partner is unwilling to use birth control\n* Active treatment for cancer, planned treatment for cancer, or recent active cancer with likelihood of recurrence or progression, which, in the opinion of the site investigator, has a likelihood of recurrence that would interfere with study therapy prior to 2028\n\n  * Treated cancer with no evidence of disease, no evidence of disease progression, and no planned change in therapy is allowed. Examples of allowable cancers include:\n  * Breast cancer stable after active treatment, managed with long-term anti-estrogen therapy\n  * Prostate cancer being observed\n  * Stage 0 or 1 tumors status post resection or other definitive treatment\n  * Other similarly stable cancer comorbidities\n* History of solid organ or bone marrow transplant\n* Allergy to SGLT2 inhibitor or GLP-1 receptor agonist",{"count":291,"type":22},6000,[293],"PHASE4","PRECIDENTD is a randomized, open label, pragmatic clinical trial designed to compare rates of the total number of cardiovascular, kidney, and death events among two alternative treatments for patients with type 2 diabetes (T2D) and either established atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD. To accomplish this objective, we will randomly assign 6,000 patients with established T2D and ASCVD or high-risk for ASCVD in a 1:1 allocation to sodium-glucose cotransporter-2 inhibitor (SGLT2i) or glucagon-like peptide-1 receptor agonists (GLP-1RA). Participants will be followed for the occurrence of the trial primary endpoint of the total (first and recurrent) number of episodes of myocardial infarction (MI), stroke, arterial revascularization, hospitalization for heart failure, development of end-stage kidney disease, kidney transplantation, and mortality, counting all events from randomization until end of study.",[296,297],"Type2Diabetes","ASCVD","2026-04-07",{"date":275,"type":37},{"date":301,"type":37},"2022-09-26",{"date":303,"type":22},"2029-03-01",{"name":281,"class":44},36,{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":312,"sex":86,"minAge":18,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":23,"phases":315,"briefSummary":316,"conditions":317,"keywords":319,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":45},"100500375","the-caring-study-creating-and-restoring-health-through-nutrition-guidance-100500375","NCT05795439","The CARING Study: Creating and Restoring Health Through Nutrition Guidance","Inclusion Criteria:\n\n1. Blue Cross Blue Shield subscriber continuously enrolled for the prior 12 months\n2. Male or female\n3. Age at least 18 years\n4. Have a diagnosis of type 2 diabetes\n5. Ability and willingness to participate in all components of the study, including:\n\n   1. Following a plant-based diet for the initial 16 weeks of the study;\n   2. Attending weekly online classes for the initial 16 weeks of the study; and\n   3. Keeping physical activity level consistent throughout the initial 16 weeks of the study.\n\nExclusion Criteria:\n\n1. Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome\n2. Smoking during the past six months\n3. Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use\n4. Current or unresolved past drug abuse\n5. Recently gave birth, pregnant, or plans to become pregnant before or during the study period\n6. Unstable medical or psychiatric status\n7. Cancer diagnosis\n8. Chronic kidney disease, stage 4 or 5\n9. Evidence of an eating disorder\n10. Lack of English fluency\n11. Bariatric surgery in the last 6 months\n12. Dementia\n13. Institutional custodial care\n14. End of life\n15. Palliative Care\n16. Actively engaged in specific BCBSM diabetes programs and case management programs",true,{"count":314,"type":22},700,[25],"The CARING study assesses the health benefits of nutrition education for Blue Cross Blue Shield subscribers, as well as potential healthcare cost savings to subscribers and the insurance company.",[28,318],"Type 2 Diabetes Treated With Insulin",[96,320,321,322],"Type2","Insulin","A1C","2026-04-06",{"date":275,"type":37},{"date":326,"type":37},"2023-07-11",{"date":328,"type":22},"2028-12",{"name":330,"class":44},"Physicians Committee for Responsible Medicine",{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":86,"minAge":262,"maxAge":88,"enrollmentInfo":339,"targetDuration":4,"studyType":23,"phases":341,"briefSummary":342,"conditions":343,"keywords":346,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":357,"locationsCount":359},"100544112","understanding-and-addressing-risks-of-low-socioeconomic-status-and-diabetes-for-heart-failure-100544112","NCT06364644","Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure","Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure (UNLOAD-Heart Failure)","UNLOAD-HF","Inclusion Criteria:\n\n* Adults from Johns Hopkins Medicine (JHM) who live in Baltimore City and adults from Johns Hopkins Community Physicians (JHCP) Hagerstown or Family Healthcare of Hagerstown who live in Washington County\n* Low socioeconomic status (SES) by high Area Deprivation Index (ADI) \\[\\>75th percentile for the state of Maryland\\] plus low income)\n* Type 2 diabetes\n* Obesity (BMI≥30 kg\u002Fm\\^2)\n\nExclusion Criteria:\n\n* Age \\\u003C 30 or \\>70 years\n* Prevalent heart failure\n* Uncontrolled glycemia (blood glucose \\\u003C60 mg\u002Fd or ≥ 300 mg\u002Fdl or most recent hemoglobin A1c ≥11%)\n* Uncontrolled blood pressure (Systolic blood pressure (SBP) ≥160 or diastolic blood pressure (DBP) ≥100 mm Hg, either on or off medications)\n* Known coronary artery disease (unless \\\u003C 50% stenosis by angiography)\n* Moderate or severe valvular heart disease\n* Serious medical conditions limiting life expectancy or requiring active management\n* Inability to participate in moderate intensity physical activity as assessed by the self-report Physical Activity Readiness Questionnaire Plus (PAR-Q+).\n* Any condition or planned surgery\u002Fprocedure precluding exercise for ≥ 150 minutes per week\n* End-stage renal disease\n* Current participation in another behavior change program\n* Active alcohol or substance abuse disorder\n* Already engaging in regular exercise with more than 60 minutes of moderate \\[3-6 METS\\] to vigorous \\[\\>6 METS\\] physical activity per week\n* Active pregnancy\n* Evidence of ischemia, dangerous arrhythmia, or other clinical instability on baseline exercise stress test",{"count":340,"type":22},210,[25],"This study aims to determine whether a 6-month multilevel intervention involving problem-solving training, exercise training and support from community health workers is more effective in improving outcomes for individuals with low socioeconomic status, type 2 diabetes, obesity, and early cardiac dysfunction than receiving education and access to a community exercise facility.",[28,344,345],"Heart Failure","Obesity",[347,96,344,348,345,349,350],"Behavioral Intervention","Exercise","Health Equity","Low Socioeconomic Status","2026-03-23",{"date":353,"type":37},"2026-03-27",{"date":355,"type":37},"2025-06-20",{"date":251,"type":22},{"name":358,"class":44},"Johns Hopkins University",2,{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":86,"minAge":19,"maxAge":171,"enrollmentInfo":367,"targetDuration":4,"studyType":23,"phases":369,"briefSummary":371,"conditions":372,"keywords":373,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":384,"locationsCount":45},"100540851","early-phase-1-type-2-diabetes-and-blood-brain-barrier-improvement-100540851","NCT06322212","Type 2 Diabetes and Blood Brain Barrier Improvement","Type 2 Diabetes Mellitus and Blood Brain Barrier Improvement - A Randomized Clinical Trial","Inclusion Criteria:\n\n* Diagnosed T2DM\n* Outpatient status\n* Able to lay flat for imaging\n\nExclusion Criteria:\n\n* A previous history of stroke\n* Current in-take of thiamine\n* Known thiamine allergy\n* Seizure disorder\n* Head trauma\n* Myocardial infarction\n* Current pregnancy (if female)\n* Diagnosed neuropsychiatric disorders (clinical depression, schizophrenia, manic-depression)\n* Diagnosed dementia\n* Sleep disordered breathing\n* Airway or chest deformities that would interfere with breathing\n* Chronic obstructive pulmonary disease\n* Cystic fibrosis\n* Presence of brain mass lesions\n* Any history of drug abuse (e.g., cocaine, tobacco, or cannabis)\n* Renal failure (requiring dialysis)\n* All T2DM adults with metallic and electronic implants (phrenic or cardiac pacemakers; although some pacemakers and cardioverter defibrillators are safe at a low magnetic field, they are not safe at 3.0-Tesla scanner)\n* Non-removable insulin pump\u002Fglucose sensor\n* Braces\n* Body weight more than 300 pounds (weight and height will be used to calculate BMI to determine if the patient will fit in the scanner and stay within parameters of size restrictions of MRI scanner table)\n* Any other contraindications to MRI, such as claustrophobia, or metallic-based tattoos, as per MRI safety website suggestions, will also be excluded.",{"count":368,"type":22},52,[370],"EARLY_PHASE1","The majority of T2DM adults show thiamine (vitamin B1) deficiency which may contribute to impaired function. This study will examine patients with T2DM through brain MRI scans, cognition assessments, blood tests, and questionnaires. Our goal is to see if a thiamine treatment (taking vitamin B1 capsules) can improve function. Patients will be asked to come to UCLA two times three months apart and each visit will last about 2.5-3 hours.",[28],[374,375,376,377],"MRI","Thiamine Treatment","Thiamine Deficiency","Cognition Assessments","2026-03-11",{"date":380,"type":37},"2026-03-13",{"date":382,"type":37},"2024-08-01",{"date":279,"type":22},{"name":385,"class":44},"University of California, Los Angeles",{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":86,"minAge":392,"maxAge":393,"enrollmentInfo":394,"targetDuration":4,"studyType":202,"phases":4,"briefSummary":396,"conditions":397,"keywords":401,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":45},"100512919","mitochondrial-substrate-utilization-in-the-diabetic-human-heart-100512919","NCT05958706","Mitochondrial Substrate Utilization in the Diabetic Human Heart","Inclusion Criteria:\n\n* Age ≥ 20 and ≤ 85 years\n* Male and female patients with manifest heart failure (NYHA II-IV) and clinical indication for myocardial biopsy or after transplantation and clinical indication for myocardial biopsy with or without type II diabetes mellitus or terminal (NYHA IV) heart failure with or without type II diabetes mellitus.\n* Written informed consent\n\nExclusion Criteria:\n\n* Acute infectious diseases within the last 2 weeks before the examination\n* Autoimmune diseases or acute immunocompromising diseases (leukocytes \\\u003C 5000\u002Fμl)\n* Pregnancy\n* Use of alcohol or drugs (addiction), psychiatric diseases\n* Suspected or manifest AIDS (HIV); hepatitis B or C.\n* Liver disease not attributed to the presence of nonalcoholic fatty liver hepatitis or congestive hepatopathy in heart failure\n* Malignant cancer\n* Lack of capacity to give informed consent or lack of consent to participate in the study\n* For MRI study with drug stress: contraindications to the use of regadenoson, specifically: a) Hypersensitivity to the active ingredient or any of the other ingredients mentioned. b) Second- or third-degree atrioventricular (AV) block or sinus node dysfunction, unless these patients have a functioning pacemaker. c) Unstable angina that has not been stabilized with medication. d) Severe hypotension. e) Decompensated stages of heart failure.","20 Years","85 Years",{"count":395,"type":22},500,"Diabetes can lead to heart failure independently, but the underlying causes remain incompletely understood. The main aim of this study is to identify differential regulation of mitochondrial substrate utilization and complex activity in heart failure and type 2 diabetes mellitus (T2DM). For this, we will conduct a prospective, observational study to examine myocardial mitochondrial oxidative function and related metabolic parameters, gene expression, histological markers, and inflammation in cardiac tissue from patients with heart failure or patients after heart transplantation. We will further assess cardiac function using cardiac magnetic resonance imaging with and without stress protocols and magnetic resonance spectroscopy. Glycemic control\u002FT2DM will be characterized by oral glucose tolerance tests. The results of this project will help to better understand the cellular mechanisms of the development of diabetic cardiomyopathy and contribute to the development of early diagnostic, as well as therapeutic approaches for the prevention and treatment of diabetic cardiomyopathy.",[344,28,398,399,400],"Insulin Resistance","Mitochondrial Diseases","Diabetic Cardiomyopathies",[402,403,404,405,180,406,407],"mitochondrial function","respirometry","heart failure","type 2 diabetes mellitus","mitochondrial disease","diabetic cardiomyopathy","2026-02-17",{"date":410,"type":37},"2026-02-19",{"date":412,"type":37},"2021-12-01",{"date":414,"type":22},"2035-06",{"name":416,"class":44},"Heinrich-Heine University, Duesseldorf",{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":86,"minAge":18,"maxAge":171,"enrollmentInfo":425,"targetDuration":4,"studyType":202,"phases":4,"briefSummary":427,"conditions":428,"keywords":436,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":45},"100517290","comorbidities-resolution-after-mgb-surgery-and-change-in-body-composition-100517290","NCT06015620","Comorbidities Resolution After MGB Surgery and Change in Body Composition","CoMOrbidities Resolution After Mini-GAstric Bypass Surgery for Morbid Obesity and Change in BOdy Composition: A Prospective Cohort Study (MOGAMBO Study)","MOGAMBO","Inclusion Criteria:\n\n* All patients undergoing laparoscopic MGB surgery for morbid obesity and it's associated comorbidities\n\nExclusion Criteria:\n\n* Patients not giving consent for the study\n* All patients who were undergoing a redo-procedure for recurrence were excluded from the study",{"count":426,"type":22},35,"This observational study aims to learn about the correlation between the improving comorbidities associated with obesity after MGB (Mini-Gastric Bypass) surgery and changes in body composition in morbidly obese patients. The main questions it aims to answer are:\n\nTo study the correlation between the improving comorbidities associated with obesity after MGB(Mini-Gastric Bypass) surgery and changes in body composition.\n\nOther objectives are:\n\n* Changes in the parameters of the metabolic syndrome after surgery\n* Changes in the cardiovascular risk biomarkers after metabolic surgery\n* Emergence in complications arising out of surgery requiring any intervention or causing a prolonged hospital stay, or requiring additional outpatient visits.\n\nType of Study: An observational study in which participants with morbid obesity will undergo mini-gastric bypass surgery as per routine protocol. No separate experimental interventions will be done in the study for the participants.",[429,28,430,431,432,433,434,435],"Morbid Obesity","Sleep Apnea","Hypothyroidism","Hypertension","Lipid Disorder","Non-Alcoholic Fatty Liver Disease","Chronic Venous Hypertension With Ulcer",[437,438,439,440,441,442,443,444,445],"morbid obesity","OSA","mini gastric bypass","metabolic surgery","polysomnography","metabolic syndrome","DEXA scan","bioelectrical impedance","body composition","2026-02-16",{"date":448,"type":37},"2026-02-18",{"date":450,"type":37},"2023-09-01",{"date":452,"type":22},"2027-03-30",{"name":454,"class":44},"All India Institute of Medical Sciences, Bhubaneswar",{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":86,"minAge":18,"maxAge":88,"enrollmentInfo":462,"targetDuration":4,"studyType":23,"phases":464,"briefSummary":465,"conditions":466,"keywords":468,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":45},"100533735","early-phase-1-ketones-sglt2-hfref-100533735","NCT06229678","Ketones, SGLT2, HFrEF","Ketones, Muscle Metabolism, and SGLT2 Inhibitors","Inclusion Criteria:\n\n* Type 2 Diabetes Mellitus\n* Class II-III New York Heart Association (NYHA) heart failure and reduced ejection fraction (EF) \\\u003C50%\n* Age 18-80 years\n* BMI 23-44 kg\u002Fm2\n* Glycated hemoglobin (HbA1c) 6.0-10.0%\n* Blood Pressure (BP) ≤ 145\u002F85 mmHg\n* Estimated glomerular filtration rate (eGFR) ≥30 ml\u002Fmin•1.73 m2\n* Only Type 2 diabetics treated with diet\u002Fexercise, metformin, sulfonylureas, metformin\u002Fsulfonylurea, Glucagon-like peptide-1 receptor agonist (GLP-1 RA), or insulin\n* Stable body weight (±4 pounds) over the previous 3 months prior to enrollment\n* Ability to understand study procedures and to comply with them for the entire length of the study.\n\nExclusion Criteria:\n\n* Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart disease, hypertrophic obstructive cardiomyopathy.\n* Significant change in diuretic management during the month prior to screening (defined by doubling of diuretic dose or addition of another heart failure medication)\n* Type 2 Diabetics treated with Dipeptidyl Peptidase-4 Inhibitor (DPP4i) or pioglitazone\n* Pregnancy, lactation, or plans to become pregnant. A negative pregnancy test will be performed before each MRI study to assess current status. For women of child-bearing age (WOCBA) willingness to use contraception, if applicable.\n* Allergy\u002Fsensitivity to study drugs or their ingredients.\n* Cancer.\n* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n* Inability or unwillingness of individual or legal guardian\u002Frepresentative to give written informed consent.",{"count":463,"type":22},71,[370],"The study team will examine the effects of elevated plasma ketone levels following initiation of SGLT2 inhibitor therapy in high-risk type 2 diabetes mellitus (T2DM) individuals with heart failure (HF) with reduced ejection fraction (HFrEF) providing an energy-rich fuel that is taken up with great avidity by the myocardium, to measure change in Left Ventricle diastolic and systolic function",[28,467],"Heart Failure With Reduced Ejection Fraction",[469,470],"ketones","cardiovascular benefit","2026-02-03",{"date":473,"type":37},"2026-02-05",{"date":475,"type":37},"2024-01-25",{"date":477,"type":22},"2027-03-01",{"name":479,"class":44},"The University of Texas Health Science Center at San Antonio",{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":312,"sex":86,"minAge":170,"maxAge":88,"enrollmentInfo":486,"targetDuration":4,"studyType":23,"phases":488,"briefSummary":489,"conditions":490,"keywords":492,"overallStatus":217,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":498,"leadSponsor":499,"locationsCount":45},"100590821","phase-2-the-effect-of-rs7903146-genotype-on-islet-glp-1-production-in-humans-100590821","NCT06972407","The Effect of rs7903146 Genotype on Islet GLP-1 Production in Humans","Inclusion Criteria:\n\n* Subjects with the TT or CC genotype at rs7903146\n\nExclusion Criteria:\n\n1. Age \\\u003C 25 or \\> 70 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).\n2. CT genotype at rs7903146\n3. HbA1c \\> 6.5%\n4. Use of any glucose-lowering agents including metformin or sulfonylureas.\n5. For female subjects: positive pregnancy test at the time of enrollment or study.\n6. History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.\n7. Active systemic illness or malignancy.\n8. Symptomatic macrovascular or microvascular disease.",{"count":487,"type":22},80,[175],"The investigators recently demonstrated that blockade of Glucagon-Like Peptide-1's (GLP-1) receptor (GLP1R) results in changes in islet function without changes in circulating GLP-1. These effects are more pronounced in people with early type 2 diabetes (T2DM) in keeping with increased expression of PC-1\u002F3 and GLP-1 that is observed in diabetic islets. However, its regulation is at present unknown. Common genetic variation in the TCF7L2 locus (T-allele at rs7903146) arguably confers the greatest genetic risk of T2DM. It is associated with α- and β-cell dysfunction. TCF7L2 (the product of TCF7L2) was first described as the transcription factor necessary for proglucagon expression in intestinal L-cells (which secrete GLP-1). This led to speculation that TCF7L2 confers risk of diabetes via changes in circulating GLP-1. This has turned out to not be the case. This raises the possibility that these diabetogenic effects are mediated via an inability of islet GLP-1 to adapt to rising glycemia. Therefore, this experiment will determine the contribution of islet GLP-1 to the functional abnormalities of the islet associated with the TCF7L2 locus.",[491,28],"Genetic Predisposition",[493],"TCF7L2","2026-01-28",{"date":496,"type":37},"2026-01-30",{"date":106,"type":22},{"date":303,"type":22},{"name":500,"class":44},"Mayo Clinic",{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":23,"phases":510,"briefSummary":511,"conditions":512,"keywords":514,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":527,"locationsCount":45},"100509101","a-randomized-controlled-trial-of-diabetes-screening-immediately-postpartum-dip-and-follow-up-pp-care-100509101","NCT05909046","A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) and Follow Up PP CARE","A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) - Follow up Study: Patient Perspectives on Postpartum Interventions to Improve Future Maternal CARdiovascular hEalth After Gestational Diabetes (PP CARE)","DIP - Inclusion Criteria:\n\n* Immediately postpartum individuals during their delivery hospital admission\n* ≥ 18 years old with the ability to give informed consent.\n* Diagnosed with GDM during pregnancy by:\n\n  * Elevated one-hour 50-gram glucose challenge test any time during pregnancy AND provider documentation of gestational diabetes (NOT pregestational diabetes) diagnosis OR\n  * Two elevated values on a 3-hour 100-gram glucose tolerance test any time in pregnancy AND provider documentation of gestational diabetes (NOT pregestational diabetes) diagnosis\n* English or Spanish speaking\n* Receiving prenatal and postpartum care at OSU\n\nDIP- Exclusion Criteria:\n\n* Individuals who cannot tolerate a 2-hour oral glucose tolerance test (OGTT) (i.e. history of gastric bypass)\n* Not English or Spanish speaking\n\nPP CARE Inclusion criteria: Enrolled DIP participants who are English speaking will be eligible for PP CARE follow up if they are between 12 and 24 months postpartum.\n\nPP CARE Exclusion criteria: Spanish speaking DIP participants will be excluded because the study team does not include anyone who is Spanish speaking.",{"count":509,"type":22},104,[25],"DIP : To conduct a pragmatic, non-blinded randomized controlled trial (pRCT) of immediate in-patient postpartum OGTT prior to delivery discharge (intervention) versus 4-12 week outpatient postpartum OGTT (current standard care) to improve the frequency of post-partum diabetes screening among individuals with a pregnancy complicated by GDM.\n\nFollow up PP CARE: To engage with individuals with a history of GDM through a patient-centered mixed-methods survey and qualitative assessment to evaluate the barriers to and facilitators of Cardiovascular health (CVH) counseling and risk-reduction postpartum at the patient and healthcare system levels inclusive of Social determinants of health (SDOH) and structural factors, as well as patient preferences and perspectives on CVH and wellness interventions",[58,28,59,60,207,513],"Gestational Diabetes Mellitus in the Puerperium",[515,63,516,517,518,519,271,520],"2-hour oral glucose tolerance test (OGTT)","diabetes mellitus screening","postpartum","cardiometabolic health","cardiovascular health","prediabetes","2025-11-19",{"date":523,"type":37},"2025-11-24",{"date":525,"type":37},"2023-07-24",{"date":34,"type":22},{"name":77,"class":44},{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":86,"minAge":534,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":23,"phases":536,"briefSummary":537,"conditions":538,"keywords":539,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":547,"locationsCount":45},"100510956","promoting-alternatives-to-sulfonylureas-to-improve-patient-safety-in-type-2-diabetes-100510956","NCT05933174","Promoting Alternatives to Sulfonylureas to Improve Patient Safety in Type 2 Diabetes","Inclusion Criteria:\n\n* Age ≥ 45 years\n* Type 2 diabetes (diagnosed on or before 12\u002F31\u002F2021)\n* Current\u002Factive prescription for one or more SU medications\n* Established care (≥2 visits) with UH primary care provider (PCP) since 2021\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* PCP provides a reason why patient participation is inappropriate (e.g., known cost barriers without any alternatives, prior discussion with patient about alternatives, etc.)\n* Patient unable or unwilling to have conversation with their PCP regarding SU\n* Unable to provide informed consent","45 Years",{"count":145,"type":22},[25],"Sulfonylurea medications are unsafe for older patients with diabetes. They are associated not only with hypoglycemia, but also with falls and increased cardiovascular risk. Yet they continue to be prescribed frequently. Indeed, older adults with type 2 diabetes, who are especially prone to adverse effects, are more likely to be prescribed sulfonylureas than younger patients. This is unfortunate since over the past several years, newer, safer, and more effective classes of medications (GLP-1 agonists and SGLT2-inhibitors) have emerged. The investigators acknowledge that sulfonylureas are inexpensive and that their low cost is a driver of continued use. However, the investigators believe patients and providers should have discussions about the risks of sulfonylureas and safer and more effective alternatives, to make diabetes care safer overall in ambulatory settings. Our research is designed to promote such discussions. The investigators will first identify patients taking sulfonylureas regularly. Next, using recommendations from AHRQ and the Canadian Deprescribing Network, the investigators will empower patients to discuss their medications with their providers through a simple question prompt sheet. Patients will be divided into an intervention group which receives explicit prompting questions, and a control group that receives a general brochure on diabetes medications. Health care providers will receive education about newer diabetes medications through case-based discussions and academic detailing. Finally the investigators will measure key outcomes including the proportion of patients who have discussions about sulfonylureas and alternatives, rates of discontinuation, and measures of control of diabetes and associated cardiovascular risks. The investigators will also evaluate the experiences of patients and providers qualitatively through brief, semi-structured interviews. Should our multi-faceted, patient-oriented intervention prove effective in promoting discussions of sulfonylureas and alternatives, and also discontinuation of sulfonylureas and switching to newer alternatives, the investigators will incorporate our prompting questions into routine care for patients taking sulfonylureas. Our intervention can be easily disseminated to other settings and therefore has considerable potential to improve safety among patients with type 2 diabetes nationwide.",[28],[540],"Sulfonylureas","2025-11-11",{"date":543,"type":37},"2025-11-13",{"date":545,"type":37},"2023-10-01",{"date":34,"type":22},{"name":548,"class":44},"Ian J. Neeland, MD",{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":553,"acronym":4,"eligibilityCriteria":554,"healthyVolunteers":312,"sex":86,"minAge":555,"maxAge":556,"enrollmentInfo":557,"targetDuration":4,"studyType":23,"phases":559,"briefSummary":560,"conditions":561,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":572},"100465302","dialectal-behaviour-therapy-to-enhance-health-behaviour-change-for-adolescents-living-with-obesity-direction-trial-100465302","NCT05338944","Dialectal Behaviour Therapy to Enhance Health Behaviour Change for Adolescents Living With Obesity (DIRECTION Trial)","Inclusion Criteria:\n\n* 14-17 years old\n* BMI z-score \\>1.4\n* signs of mild-moderate depression (PHQ-9 score 5-19)\n* willing and able to comply with study procedures\n\nExclusion Criteria:\n\n* more than one health co-morbidity\n* being treated with medication for obesity\n* taking steroids\n* currently being treated for atypical antipsychotics\n* have an orthopedic injury or chronic illness that would prevent them from performing the intervention\n* experienced weight loss or enrolled in weight loss program in the six months prior to the study\n* they are currently and\u002For in the past 12 months have been prescribed any weight loss medication(s) including Ozempic\n* self reported history of alcoholism or drug abuse\n* history of self-harm or suicide attempts in the past 12 months\n* currently enrolled in psychotherapy or DBT\n* parents do not approve of you participating\n* unable to read, speak and understand English as translation will not be provided\n* unable\u002Funwilling to give assent\u002Fconsent","14 Years","17 Years",{"count":558,"type":22},90,[25],"This research is being conducted to evaluate emotion-focused therapy that incorporates elements of mindfulness, distress tolerance, and relationship support. The investigators want to learn if this therapy, called Dialectical Behavioral Therapy (DBT) will help improve quality of life and weight management in youth at risk for type 2 diabetes. Individuals will be randomly assigned to weekly group based session in one of 3 intervention arms; lifestyle + DBT, lifestyle alone, or a control arm.",[562,296],"Prevention","2025-10-02",{"date":565,"type":37},"2025-10-07",{"date":567,"type":37},"2023-01-14",{"date":569,"type":22},"2027-01-31",{"name":571,"class":44},"University of Manitoba",3,{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":577,"acronym":4,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":86,"minAge":18,"maxAge":579,"enrollmentInfo":580,"targetDuration":4,"studyType":23,"phases":582,"briefSummary":583,"conditions":584,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":592,"locationsCount":45},"100485607","non-weight-bearing-exercise-for-accelerated-healing-of-diabetic-foot-ulcers-100485607","NCT05603273","Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or Female, aged 18 yrs or older\n4. Diabetes diagnosed or meets ADA criteria for Type 2 diabetes\n5. Foot ulcer of diabetic etiology, with all of the following characteristics:\n\n   * Ulcer size \\> 0.5cm2 and \\\u003C 12cm2 at least 2 cm from any other ulcer\n   * Ulcer with Wagner grade 1 or 2\n6. In case of multiple ulcers, select the largest ulcer that meets inclusion criteria.\n\nExclusion Criteria:\n\n1. Patient participating in an interventional clinical trial within 1 month of visit 1\n2. Participant has Charcot's foot or other foot deformities that prevent adequate targeted ulcer offloading\n3. Participant has active severe infection or osteomyelitis at the time of the screening visit\n4. History of cancer within the last 3 years, other than non-melanoma skin cancer\n5. Use of adjunctive therapy within previous 30 days\n6. Currently receiving medication considered to be a systemic glucocorticoid\n7. Plan to perform a vascular intervention, such as surgical bypass, angioplasty or stenting, or \\\u003C 1 month from a prior ipsilateral (same side) vascular intervention\n8. Pregnant or currently lactating\n9. Uncontrolled blood glucose with presence of urinary ketones\n10. Contraindications for exercise as define by the American Heart Association\u002FAmerican College of Sports Medicine Guidelines for Exercise Testing and Prescription \\[1\\]\n11. Bilateral wound or ulcer\n12. Current infection of COVID19\n13. Any history of concomitant medical condition that, in the opinion of the investigator(s), would compromise the participants ability to safely complete the study","75 Years",{"count":581,"type":22},40,[25],"The goal of this study is to improve the therapeutic management of diabetic foot ulcers (DFU). The main questions to answer are if a program of non-weight bearing exercise helps the DFU heal faster than standard wound care. This randomized clinical trial will determine how blood flow to the ulcer and whole body metabolism may be improved with exercise. Participants will be randomized to either exercise + standard wound care or standard wound care alone and undergo testing for leg blood flow, fitness and measures of metabolism through blood draws. The intervention period is 6-weeks. Eligible participants must have an existing foot ulcer uncomplicated by infection and be medically cleared to exercise.",[28,585],"Foot Ulcer","2025-09-17",{"date":588,"type":37},"2025-09-18",{"date":590,"type":37},"2023-12-13",{"date":34,"type":22},{"name":593,"class":44},"University of Michigan",{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":86,"minAge":18,"maxAge":171,"enrollmentInfo":602,"targetDuration":4,"studyType":23,"phases":603,"briefSummary":604,"conditions":605,"keywords":609,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":623},"100534292","susceptibility-to-infectious-diseases-in-obesity-an-endocrine-translational-sociologic-evaluation-siderale-100534292","NCT06236932","Susceptibility to Infectious Diseases in obEsity: an endocRine trAnslational socioLogic Evaluation, \"SIDERALE\"","PRIN \"SIDERALE\": Susceptibility to Infectious Diseases in obEsity: an endocRine trAnslational socioLogic Evaluation","SIDERALE2020","Inclusion Criteria:\n\n* essential obesity (BMI : 30-35 Kg\u002Fm2)\n* genetic forms of obesity (BMI: 30-35 Kg\u002Fm2)\n* obesity (BMI:30-35 Kg\u002Fm2) associated with T2DM\n* obesity (BMI:30-35 Kg\u002Fm2) associated with endocrinopathies\n* lipodystrophy\n\nExclusion Criteria:\n\n* pregnancy, breast-feeding, alcohol and drug abuse, known severe haematological, cardiac, liver, kidney, mental diseases, hypogonadisms, hormonal treatments including estroprogestins, intolerance to melatonin or excipients",{"count":119,"type":22},[25],"Obesity is a life-threatening disease, defined by excessive fat accumulation that increases the risk of other diseases such as cardiovascular events, hypertension, diabetes and cancer. Obesity is also a risk factor for nosocomial infections and is associated with worse COVID-19 outcomes, although anthropometric measurements are not routinely recorded during hospitalization and lack of a registry data does not allow performing retrospective studies.Obesity is closely related to chronodisruption, characterized by deregulation of physiological and behavioral central and peripheral circadian rhythms contributing to the obesity-related metabolic impairment. Eating and sleeping time schedules are relevant synchronizers of humans' biological clock. Several studies suggest a role of dietary interventions in rewiring the circadian rhythm, with Mediterranean diet (MD) regulating nutritional patterns. Moreover, considering its positive impact on sleep quality, melatonin intake was suggested as a potential regulator of circadian rhythms. The relation between chronodisruption, obesity and infections has not been investigated, and a first proof of concept (Pilot study) will aim at investigating it. Three cohorts of obese patients with different aetiology (essential obesity, obesity with type 2 diabetes, genetic forms of obesity) and a cohort of lipodystrophic patients will be enrolled in the study, which is designed as a two-phases protocol. During the first phase (0-12 weeks (w)) patients will be subjected to dietary intervention with hypocaloric MD; in a second phase (12-24w), melatonin 1mg\u002Fdie before sleep will be added to the hypocaloric MD. The susceptibility to infections will be investigated through the evaluation of 1) the number of events - i.e. flu- or flulike syndromes, skin, respiratory, digestive, urinary infections-per patient of the 4 groups and the blood assays to detect the infection with Epstein-Barr, Cytomegalovirus, Varicella, Measles and SARS-CoV-2 IgG and IgM; hepatitis C and hepatitis B core antibodies and Quantiferon TB Gold, 2) the clock genes rhythm and TLRs expression in patient immune cells at baseline, 12w and 24w.The mutual relationship between biomedical values, environmental and social conditions, and lifestyle habits will be evaluated by structured questionnaires. Validation of questionnaires to explore the susceptibility to infections is another delivery planned for the current study.",[345,28,606,607,608],"Lipodystrophy","Infections","Obesity Associated Disorder",[345,607,610,611,612,613],"Melatonin","Mediterranean Diet","Gut microbiota","Chronobiology","2025-08-07",{"date":616,"type":37},"2025-08-12",{"date":618,"type":37},"2023-12-29",{"date":620,"type":22},"2026-10-29",{"name":622,"class":44},"Federico II University",4,{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":629,"acronym":4,"eligibilityCriteria":630,"healthyVolunteers":12,"sex":86,"minAge":18,"maxAge":4,"enrollmentInfo":631,"targetDuration":4,"studyType":23,"phases":633,"briefSummary":634,"conditions":635,"keywords":637,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":45},"100542049","fiber-supplementation-in-heart-failure-with-preserved-ejection-fraction-hfpef-100542049","NCT06337812","Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF)","Fiber Supplementation to Increase Short Chain Fatty Acid Production in Patients With Type II Diabetes and Heart Failure With Preserved Ejection Fraction - the FERMENT HFpEF Trial","Inclusion Criteria:\n\n* A confirmed clinical diagnosis of stable HFpEF on maximally tolerated Heart Failure (HF) medical regimen (without changes in dosage in the prior month)\n* Left ventricular ejection fraction of \\>50% documented in the prior 12 months\n* A confirmed clinical diagnosis of Type II diabetes (T2DM) with glycated hemoglobin \\\u003C10% without changes in medical regimen in the past month.\n\nExclusion Criteria:\n\n* Current usage of pre- or probiotic usage\n* Antibiotic usage in the past 6 months\n* Current participation in another interventional clinical trial\n* History of potato allergy or potato starch allergy, inflammatory bowel syndrome, inflammatory bowel disease, bowel resection, Roux-en-Y gastric bypass surgery, celiac disease, Crohn's disease, or colorectal cancer\n* Hypoglycemic episode with blood glucose 70 milligrams per deciliter (mg\u002FdL) within the last month\n* Stage IV-V chronic kidney disease\n* Pregnancy (self-reported)\n* Comorbidity limiting survival to \\\u003C 12 months",{"count":632,"type":22},30,[25],"The study team is studying how increasing dietary fiber, specifically through adding potato starch to participant's diet, may impact the species of bacteria in participant's gut microbiome. The study team also wants to understand if adding potato starch to participant's diet helps these bacteria make more short chain fatty acids, a byproduct the team thinks may benefit participant's health.",[28,636],"Heart Failure With Preserved Ejection Fraction",[638,639,640,641],"Fiber Supplementation","Potato Starch","Gut microbiome","Resistant starch","2025-07-22",{"date":644,"type":37},"2025-07-24",{"date":646,"type":37},"2024-04-01",{"date":648,"type":22},"2026-12",{"name":593,"class":44},{"id":651,"slug":652,"hasResults":12,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":4,"eligibilityCriteria":656,"healthyVolunteers":12,"sex":86,"minAge":657,"maxAge":579,"enrollmentInfo":658,"targetDuration":4,"studyType":23,"phases":660,"briefSummary":661,"conditions":662,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":665,"lastUpdatePostDateStruct":666,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":671,"locationsCount":673},"100520243","phase-4-sglt2-inhibition-in-addition-to-lifestyle-intervention-and-risk-for-complications-in-subtypes-of-patients-with-prediabetes-100520243","NCT06054035","SGLT2 Inhibition in Addition to Lifestyle Intervention and Risk for Complications in Subtypes of Patients With Prediabetes","SGLT2 Inhibition in Addition to Lifestyle Intervention and Risk for Complications in Subtypes of Patients With Prediabetes - a Randomized, Placebo Controlled, Multi-center Trial","Inclusion criteria:\n\n1. Male, female or intersexualpatients aged between 35 and 75 years (including)\n2. Prediabetes (defined by one of the following: FG ≥ 100 mg\u002FdL or 2h OGTT glucose ≥ 140 mg\u002FdL)\n3. BMI ≥20 kg\u002Fm2\n4. TSH within normal range\n5. Ability to understand and follow study-related instructions\n6. Negative pregnancy test for premenopausal women (blood)\n7. Patients who are receiving thyroid replacement therapy must be on a stable treatment regimen for at least 3 months prior to the screening visit (V-1)\n8. Patients who are receiving antihypertensive medication such as mineralocorticoid receptor antagonists must be on a stable treatment regimen for at least 6 weeks prior to the screening visit (V-1)\n9. Patients who are treated antihypertensive medication such as ACE inhibitors and AT1receptor antagonists, thiazides as well as loop diuretics must be on stable treatment for at least 2 weeks\n10. Understand and voluntarily sign an informed consent document prior to any study related assessments\u002Fprocedures.\n11. Patients will not be included in the study if, in the opinion of the investigator participation will lead to an unacceptable risk to the subjects' safety or well-being\n\nExclusion Criteria\n\n1. Manifest diabetes mellitus\n2. eGFR (as calculated by the CKD-EPI equation) \\\u003C 60 ml\u002Fmin\u002F1.73 m2\n3. all glucose altering medications (including current therapy with dapagliflozin or empagliflozin or any other SGLT2-Inhibitor)\n4. Symptomatic chronic congestive heart disease\n5. New diuretic or antihypertensive medication or dosing changes within the last 2 weeks, for aldosterone antagonists within the last 6 weeks\n6. known or suspected orthostatic proteinuria\n7. any acute severe or chronic severe illness, including the following: malignant disease ongoing or \\\u003C 5 years ago, unstable cardiovascular disease or procedure within 3 months prior to enrolment or expected to require coronary revascularisation procedure\n8. history of or current therapy for congestive heart failure (NYHA III and IV), pacemaker or aortic stenosis \\> II°\n9. acute pancreatic disease (i.e. elevated lipase 3x ULN)\n10. rapidly progressing renal disease or anuria\n11. known HIV infection or positive HIV test at screening\n12. history of or planned organ transplantation\n13. history or presence of inflammatory bowel disease or other severe gastrointestinal diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis\n14. relevant hepatic disease, including, but not limited to, acute hepatitis, chronic active hepatitis, or severe hepatic insufficiency, including patients with alanine aminotransferase and\u002For aspartate aminotransferase \\> 3 x upper limit of normal and\u002For total bilirubin (TB) \\> 2 mg\u002FdL (\\> 34.2 μmol\u002FL) (patients with TB \\> 2 mg\u002FdL \\[\\> 34.2 μmol\u002FL\\] and documented Gilbert's syndrome will be allowed to participate).\n15. treatment with glucocorticoids\n16. antibiotic treatment within the last 4 weeks\n17. History of ketoacidosis\n18. history of repeated urogenital infection\n19. hemoglobinopathies, haemolytic anaemia, or chronic anaemia (haemoglobin concentration \\\u003C12.0 g\u002FdL)\n20. presence of psychiatric disorder or new intake of antidepressant or antipsychotic agents(start within last 3 months)\n21. Positive Screening for a severe depression (BDI ≥29)\n22. history of hypersensitivity to the study drug or its ingredients\n23. more than 5% weight loss in the last 3 months\n24. Pregnant or breastfeeding women\n25. Subject (male, female or intersexual) is not willing to use highly effective contraceptive methods during treatment and for 14 days (male or female) after the end of treatment (highly effective methods are defined as: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence).\n\n    Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the trial participant and that the vasectomized partner has received medical assessment of the surgical success.\n26. Current participation in other interventional clinical trials or treatment with other IMPs within five times the half-life of the drug\n27. Previous therapy with dapagliflozin or other drugs that can potentially lead to overlapping toxicities within five times the half-life of the drug\n28. Patients who do not want to be informed about accidental findings\n29. Any other clinical condition that would jeopardize subjects' safety or well-being while participating in this clinical trial\n30. Patients will not be included in the study if, in the opinion of the investigator, participation leads to an unacceptable risk to their safety and well-being","35 Years",{"count":659,"type":22},170,[293],"More than 50% of patients with type 2 diabetes develop micro- and\u002For macrovascular complications during the course of the disease. Additionally, many patients at risk for diabetes develop metabolically driven complications including kidney and heart disease. Thus, it is of utmost importance to improve prevention of T2D and with this complications. Remission of prediabetes, i.e. normalization of hyperglycemia by means of lifestyle intervention is one of the most effective ways to prevent the development of T2D and complications. Novel sub-phenotyping analysis identified clusters of risk for diabetes associated with different complications, opening opportunities to new therapeutic approaches, despite and in addition to lifestyle changes. So far, pharmacological therapy is not indicated for patients with prediabetes. Remission of hyperglycemia associated with prediabetes during lifestyle interventions not only prevents T2D but is also linked with reduced albuminuria and lower microvascular and kidney complications. Thus, reaching normoglycemia (i.e. prediabetes remission) is important for reducing the risk of (pre-)diabetes-associated complications including micro- and even macrovascular disease. In patients with T2D, recent data show that dapagliflozin can improve diabetes remission, and thus, likely complications. However, to date no data have assessed whether or not this is also true in patients with hyperglycemia related to prediabetes which, as outlined above, already causes different complications.\n\nSubphenotyping of patients with newly onset diabetes suggests that for some individuals, it would be too late to start interventions against dagainst complications at the time of diagnosis of type 2 diabetes. Therefore, individuals at elevated risk to develop T2D and complications should receive preventive measures well before the diagnosis of T2D. This study will provide evidence whether such an early intervention contributes to the remission of hyperglycemia related to prediabetes to protect from associated complications such as renal disease. The studied population will comprise individuals who have hyperglycemia in the range of prediabetes and are thus prone to not only develop T2D, but also early nephropathy but in clinical practice do not receive medical treatment due to the early stage of the disease. These subjects will receive Dapagliflozin 10 mg or Placebo for 6 months. The placebo treatment arm reflects current practice. In order guarantee a benefit the patients in the placebo arm will receive a lifestyle intervention.",[28,663,664],"PreDiabetes","Renal Failure","2025-07-21",{"date":644,"type":37},{"date":668,"type":37},"2023-10-26",{"date":670,"type":22},"2027-09-30",{"name":672,"class":44},"University Hospital Tuebingen",9,{"id":675,"slug":676,"hasResults":12,"nctId":677,"briefTitle":678,"officialTitle":679,"acronym":680,"eligibilityCriteria":681,"healthyVolunteers":12,"sex":86,"minAge":262,"maxAge":88,"enrollmentInfo":682,"targetDuration":4,"studyType":23,"phases":684,"briefSummary":685,"conditions":686,"keywords":687,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":692,"lastUpdatePostDateStruct":693,"startDateStruct":694,"completionDateStruct":696,"leadSponsor":698,"locationsCount":45},"100532342","depletion-of-liver-fat-in-type-2-diabetes-100532342","NCT06211556","Depletion of Liver Fat in Type 2 Diabetes","A Parallel Group Randomized Trial Investigating the Effect of Hepatic Fat Depletion Via a Very-low Calorie Diet on Hepatokine Secretion and Function in People With Type 2 Diabetes","DepLiv","Inclusion Criteria:\n\n* Men and women 30-70 years of age\n* The target population is persons with type 2 diabetes. I.e., persons are eligible if they are diagnosed with type 2 diabetes either only with metformin for managing glucose or without use of glucose lowering medications. Persons with a HbA1c ≥ 48 mmol\u002Fmol with or without the use of glucose lowering medications are also eligible. Any glucose lowering medications other than metformin are disallowed (described under \"Exclusion criteria, below)\n* Diabetes duration \\\u003C 7 years\n* Body Mass Index (BMI) ≥ 30 kg\u002Fm2 and ≤ 40 kg\u002Fm2\n* Accepts medical regulation by the study endocrinologist\n* Inactivity, defined as \\\u003C 1,5 hours of structured physical activity pr. week at moderate intensity and cycling \\\u003C 30 minutes\u002F5 km pr. day at moderate intensity (moderate intensity = out of breath but able to speak)\n\nExclusion Criteria:\n\n* HbA1c ≥ 75 mmol\u002Fmol with no glucose lowering medications\n* HbA1c ≥ 64 mmol\u002Fmol with mono glucose lowering therapy (if compliant with the prescription)\n* HbA1c ≥ 57 mmol\u002Fmol with ≥ dual glucose lowering therapy (if compliant with the prescription)\n* Diagnosis of Type 1 diabetes, MODY-diabetes, Type 1½ diabetes or LADA-diabetes\n* eGFR\\\u003C60mL\u002Fmin (assessed via screening blood sample)\n* Treatment with any glucose-lowering medications other than metformin (e.g., insulin (long and\u002For short acting), sulphonylurea based drugs, glucagon-like peptide 1 receptor agonists, dipeptidyl peptidase 4 inhibitors, sodium-glucose co-transporter-2 inhibitors, thiazolidinediones, alpha-glucosidase inhibitors)\n* Presence of metal in the body that would contraindicate an MRI scan\n* Known or signs of intermediate or severe microvascular complications to diabetes (retino-, neuro- or nephropathy)\n* Known cancer\n* Lung disease, other than asthma that can be managed with beta2-agonists and does not exhibit seasonal variation\n* Known cardiovascular disease\n* Known hyperthyroid disease\n* Clinical or biochemical signs of hypothyroid disease\n* Changes in hypothyroid disease treatment within the last 3 three months prior to enrolment\n* Known liver disease - defined as ALAT or ASAT elevated three times above upper limit\n* Known autoimmune disease\n* Psoriasis disease requiring systemic treatment or cutan elements bigger than a total area of 25 cm2\n* Other endocrine disorder causing obesity\n* Current treatment with anti-obesity medication\n* Current treatment with anti-inflammatory medication\n* Weight loss of \\> 5kg within the last 6 months\n* Changes in symptoms or anti-depressive medication three months prior to enrolment\n* Diagnosis of psychiatric disorder or treatment with anti-psychotic medication\n* History of suicidal behavior or ideations within the last three months prior enrolment\n* Previous surgical treatment for obesity (excluding liposuction \\> 1 year prior to enrolment)\n* Pregnant\u002Fconsidering pregnancy, or lactating\n* Functional impairments that prevent the performance of intensive exercise\n* Participation in other research intervention studies\n* Macroalbuminuria at pre-screening (assessed via screening blood sample)\n* Biochemical sign of other major diseases\n* Presence of circulating glutamatdecarboxylase anti body (GAD) 65 (assessed via screening blood sample)\n* Objective findings that contraindicate participation in intensive exercise\n* Incidental findings that contraindicate participation in the study\n* Unable to allocate the needed time to fulfill the intervention\n* Language barrier, mental incapacity, unwillingness, or inability to understand and be able to complete the interventions",{"count":683,"type":22},42,[25],"The aim of this randomized trial is to determine whether liver fat depletion via a short-term (i.e., two weeks) very-low calorie diet will restore the normal exercise-induced secretion of a signaling protein (fibroblast growth factor 21) from the liver in people living with type 2 diabetes. Participants will have their liver fat, body composition, and various markers of metabolic health assessed and then will be randomized to either the very-low calorie diet intervention or a free-living control group for two weeks. Upon completion of the two-week intervention period, participants will redo all of the pre-intervention assessments. The changes in the assessments from before vs. after the intervention period will be compared between the two intervention groups (i.e., the very-low calorie diet group vs. the free living control group).",[28,345],[688,348,64,689,690,691],"VLCD","hepatokines","Hepatic steatosis","Liver fat","2025-07-17",{"date":642,"type":37},{"date":695,"type":37},"2024-02-01",{"date":697,"type":22},"2026-03",{"name":699,"class":44},"Rigshospitalet, Denmark"]