[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"type-2-diabetes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:type-2-diabetes":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,364,0,25,[9,57,79,109,133,163,193,216,245,270,291,319,343,362,385,408,432,452,477,516,554,583,604,626,654],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100652959","screening-for-obstructive-sleep-apnea-in-high-risk-patients-in-a-danish-rural-population-a-pilot-feasibility-study-100652959",false,"NCT07778121","Screening for Obstructive Sleep Apnea in High-risk Patients in a Danish Rural Population: A Pilot Feasibility Study","Screening for Obstructive Sleep Apnea in High-risk Patients in a Danish Rural Population","Inclusion Criteria:\n\n* Age 18 years or above\n* Diagnosed with type 2 diabetes mellitus\n* Resident in Region Zealand, Denmark\n* Understand and speak Danish\n\nExclusion Criteria:\n\n* Previously undergone surgery for OSA\n* Currently or within the last month used treatment for OSA such as CPAP, sleep position trainer, mandibular advancement devices etc.\n* Having an Implanted Cardioverter Defibrillator (ICD)\n* Clinically suspected of a sleep disorder other than OSA that might compromise the intended purpose of the devices",true,"ALL","18 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"NA","Background:\n\nObstructive sleep apnea (OSA) is a sleep disorder characterized by recurrent collapse of the upper airway during sleep, resulting in intermittent hypoxia and fragmented sleep. The condition is more prevalent among individuals with hypertension, atrial fibrillation, type 2 diabetes, and other chronic diseases compared with the general population. Evidence indicates that untreated OSA is associated with adverse health outcomes, whereas treatment of OSA provides significant clinical benefits. However, a substantial proportion of individuals with OSA remain undiagnosed, highlighting the need to improve detection and reduce underdiagnosis.\n\nDevices currently used to diagnose OSA are not suitable for screening; however, newer alternatives may be appropriate.\n\nThe study:\n\nThis study is a pilot feasibility study. All participants will undergo an interview and examination at a baseline visit and will subsequently use OSA testing devices at home for three consecutive nights. The study includes a questionnaire assessing participants' experience with the devices and technology in general. The objective of this study is to test the feasibility of conducting a study in which adult participants with type 2 diabetes undergo three different home sleep apnea tests over three nights, including issues to be optimized in a subsequent main\u002Fdefinitive study.\n\nThe main study aims to assess the diagnostic agreement between the devices and will be registered independently.",[28,29],"Type 2 Diabetes","Obstructive Sleep Apnea (OSA)",[31,32,33,34,35,36,28,37,38,39,40,41,42,43],"Home Sleep Apnea Test","HSAT","NightOwl","SleepImage","OSA","Obstructive Sleep Apnea","Peripheral Arterial Tonometry","Cardiopulmonary coupling","Screening","Feasibility","Pilot","Nox T3","Cardiorespiratory Monitor","RECRUITING","2026-08-20",{"date":47,"type":48},"2026-08-21","ACTUAL",{"date":50,"type":48},"2025-10-20",{"date":52,"type":22},"2026-10-01",{"name":54,"class":55},"Zealand University Hospital","OTHER",1,{"id":58,"slug":59,"hasResults":12,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100651033","a-study-to-test-whether-survodutide-helps-people-with-type-2-diabetes-control-their-blood-sugar-100651033","NCT07754461","A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar","A Phase III, Randomised, Double-blind, Parallel-group, 56-week Study, Evaluating the Efficacy and Safety of Survodutide (BI 456906), Compared With Placebo, in Participants With Type 2 Diabetes, as an Adjunct to Diet and Physical Activity Alone or in Combination With Either Oral Antidiabetic Medications or Insulin","Inclusion criteria:\n\n1. Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \\>18 years\n2. Diagnosed with type 2 diabetes mellitus (T2D) (e.g. American diabetes association (ADA)\u002FEuropean association for the study of diabetes (EASD) guidelines) and must meet requirements for one of background therapy parts A, B or C:\n\n   1. Part A: Naïve to insulin therapy and have not used oral or injectable anti-hyperglycaemic (diabetes) medication for at least 90 days prior to screening (Visit 1) and glycosylated haemoglobin A1c (HbA1c) ≥7.0 (≥53 mmol\u002Fmol) and \\\u003C9.5% (\\\u003C80 mmol\u002Fmol) as measured by the central laboratory at screening (Visit 1);\n   2. Part B: Treated with stable dose of oral antidiabetic medication (OAD) for 90 days prior to screening (Visit 1) as monotherapy or combination of: Maximum tolerated dose of metformin and\u002For Maximum tolerated dose of sulfonylurea and\u002For Maximum tolerated dose of sodium-glucose cotransporter 2 inhibitor (SGLT2i) and HbA1c ≥7.0% (≥53 mmol\u002Fmol) and \\\u003C10.5% (\\\u003C91 mmol\u002Fmol) as measured by the central laboratory at screening (Visit 1);\n   3. Part C: Stable use of basal insulin at a dose of ≥20 international units (IU)\u002Fday with or without stable dose of metformin and\u002For SGLT2i for 90 days prior to screening (Visit 1) and HbA1c ≥7.0% (≥53 mmol\u002Fmol) and \\\u003C10.5% (\\\u003C91 mmol\u002Fmol) as measured by the central laboratory at screening (Visit 1)\n3. Body mass index (BMI) ≥23 kg\u002Fm2 at screening (Visit 1)\n4. Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial\n5. Woman (or women) of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per international council for harmonisation of technical requirements for pharmaceuticals for human use M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.\n6. In the investigator's opinion, participants are well-motivated, capable, and willing to: Learn how to self-inject the investigational medicinal product (IMP), as required for this protocol (persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IMP); Inject the IMP or accept injection from a designated person; Follow study procedures for the duration of the study, including, but not limited to: follow lifestyle advice (for example, dietary restrictions and exercise plan), maintain a diary, complete required questionnaires, and handle the IMP as described in the instructions for use (IFU)\n\nExclusion criteria:\n\n1. Type 1 diabetes mellitus (T1D) or latent autoimmune diabetes in adults (LADA)\n2. Treatment within 90 days before screening (Visit 1) up to and including randomisation (Visit 2) with any: glucagon-like peptide-1 receptor (GLP-1R) agonists including GLP-1R agonist\u002Fglucose-dependent insulinotropic polypeptide (GIP) combinations, amylin or incretin combinations; Glucose-lowering drugs other than stated in the inclusion criteria for each part (i.e. metformin, Sodium-Glucose Cotransporter 2 Inhibitor (SGLT2i), basal insulin, depending on the background therapy part); Glucose-lowering investigational drug; Any anti-obesity medication including bupropion\u002Fnaltrexone, orlistat, phentermine, and phentermine\u002Ftopiramate\n3. History of ketoacidosis or hyperosmolar state or coma within the last 6 months before screening (Visit 1) up to and including randomisation (Visit 2)\n4. Hypoglycaemia unawareness or a history of severe hypoglycaemia within the last 3 months before screening (Visit 1) up to and including randomisation (Visit 2)\n5. Diabetic retinopathy or maculopathy currently under treatment, or that is reasonably anticipated to require such treatment over the duration of the study\n6. Body weight change (self-reported) \\>5% within 90 days before screening (Visit 1)\n7. Previous or planned (during the trial period) treatment for obesity with surgery or a weight loss device, including any prior bariatric surgery. The following are allowed: (1) liposuction and\u002For abdominoplasty, if performed \\>1 year before screening (Visit 1), (2) lap banding, if the band has been removed \\>1 year before screening (Visit 1), (3) intragastric balloon, if the balloon has been removed \\>1 year before screening (Visit 1), (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \\>1 year before screening (Visit 1).\n8. Answered \"yes\" to any of the suicide-related behaviours (Actual attempt, Interrupted attempt, Aborted attempt, Preparatory act or behaviour) or to the non-suicidal self-injurious behaviour question on the \"Suicidal Behaviour\" section of the Columbia-Suicide Severity Rating Scale (C-SSRS) related to the past 2 years before screening (Visit 1) up to and including randomisation (Visit 2)\n9. Further exclusion criteria apply.",{"count":65,"type":22},600,[67],"PHASE3","This study aims to find out whether a study medicine called survodutide helps people control their blood sugar. Adults who live with type 2 diabetes and with a body mass index (BMI) of 23 kg\u002Fm2 or higher can join.\n\nThe study has 3 parts. In each part the study compares survodutide with placebo. Survodutide is being developed to treat several health problems including type 2 diabetes. Placebo looks like survodutide but does not contain any medicine.\n\nDepending on a person's diabetes treatment, a person will be assigned either to\n\n* Part A: healthy eating and physical activity\n* Part B: diabetes tablets (no injection of insulin)\n* Part C: injection of insulin (with or without diabetes tablets)\n\nParticipants are randomly put into 1 of 3 groups, which means the group is chosen by chance. Two groups of participants get survodutide at different dose levels, and the third group gets placebo as injection under the skin once a week. You have a 2 in 3 chance of getting survodutide. During the study, participants continue their regular diabetes treatment.\n\nParticipants are in the study for about 1 year and 2 months. During this time, they attend up to 12 visits at the site and receive at least 9 phone calls. Study doctors regularly test participants' blood sugar by checking their HbA1c values and other laboratory test results. The study doctor also regularly checks participants' health and takes note of any changes. For each study part, the results will be compared between the survodutide and the placebo group to see whether the treatment works.",[28],{"date":47,"type":48},{"date":72,"type":22},"2026-08-24",{"date":74,"type":22},"2028-05-01",{"name":76,"class":77},"Boehringer Ingelheim","INDUSTRY",120,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100648060","legume-flour-particle-size-and-metabolic-responses-to-bread-100648060","NCT07716059","Legume Flour Particle Size and Metabolic Responses to Bread","Effects of Legume Flour Particle Size on Postprandial Metabolic Responses to Bread of Healthy Subjects and Patients With Type 2 Diabetes","PULSE","Cohort Healthy Participants\n\nInclusion Criteria:\n\n* Age: Adults aged 18-35 years.\n* Health Status: Healthy individuals with no diagnosed chronic diseases, including diabetes, cardiovascular disease, or gastrointestinal disorders.\n* Body Mass Index (BMI): 18.5-27 kg\u002Fm² (normal to overweight range).\n* Fasting Glucose: Normal fasting plasma glucose (\\\u003C100 mg\u002FdL or \\\u003C5.6 mmol\u002FL).\n* No regular use of medications known to affect glucose metabolism (e.g., insulin, metformin, corticosteroids).\n* Ability and willingness to comply with study procedures, including continuous glucose monitoring and standardized test meals.\n* Informed Consent: Ability to understand and provide written informed consent.\n\nExclusion Criteria:\n\n* Diagnosed chronic diseases: Diabetes (type 1 or type 2), cardiovascular disease, kidney or liver disease, gastrointestinal disorders (e.g., celiac disease, inflammatory bowel disease).\n* Abnormal glucose metabolism: Fasting plasma glucose ≥100 mg\u002FdL (≥5.6 mmol\u002FL) or HbA1c ≥5.7%.\n* Medication use: Regular use of medications that affect glucose metabolism, insulin sensitivity, or digestion (e.g., metformin, corticosteroids, GLP-1 analogs).\n* Allergies or intolerances: Allergy or intolerance to wheat, chickpeas, gluten, or other ingredients used in the study foods.\n* Pregnancy or lactation: Women who are pregnant, breastfeeding, or planning pregnancy during the study period.\n* Recent major weight change: Significant weight loss or gain (\\>5% body weight) in the past 3 months.\n* Extreme physical activity: Competitive athletes or individuals engaging in extreme exercise regimens that could influence glucose metabolism.\n* Inability to comply: Individuals unable or unwilling to follow study procedures, including continuous glucose monitoring and standardized test meals.\n\nCohort 2: Participants with Type 2 Diabetes Mellitus\n\nMen and women aged 40-75 years. Body mass index (BMI) \\\u003C 31 kg\u002Fm². Fasting plasma glucose \\> 125 mg\u002FdL. HbA1c \\\u003C 8.5%. Diagnosis of type 2 diabetes mellitus (T2DM) for at least 1 year before enrolment.\n\nStable treatment with hypoglycaemic, lipid-lowering, and\u002For antihypertensive medications for at least 3 months prior to enrolment.\n\nMost participants will be recruited from the Diabetes Clinic of the 1st Propaedeutic Department of Internal Medicine, Laiko General Hospital.\n\nExclusion criteria\n\nEndocrine, cardiovascular, pulmonary, renal, or gastrointestinal disorders that could affect study outcomes.\n\nSensitivity, intolerance, or allergy to any ingredients of the study breads. Pregnancy or breastfeeding. Eating disorders. Use of medications or dietary supplements considered incompatible with the study protocol.","75 Years",{"count":89,"type":22},35,[25],"The aim of the study is to investigate the effect of partial replacement of wheat flour by legume flour of different particle sizes on postprandial glucose responses and appetite sensations in healthy subjects and patients with type 2 diabetes.\n\nSubjects will consume a portion of bread enriched with legume flours yielding 50 g of available carbohydrates as breakfast meal. To investigate the effect of the bread on glycemic response, a continuous glucose monitoring system (CGM) will be used. After an 180-min period, subjects will be given a second meal and glycemic response will be monitored for another 180 min. During the trial subjects must fill appropriate visual analogue scales regarding appetite sensations.",[28],[94,95,96,97,98,99,100],"flour milling","legume seeds","Continuous glucose monitoring","particle size","T2DM","Subjective appetite sensations","postprandial glycemic response",{"date":47,"type":48},{"date":103,"type":48},"2025-09-29",{"date":105,"type":22},"2026-11-30",{"name":107,"class":55},"Harokopio University",2,{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":87,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100585062","phase-2-a-study-of-ly3457263-compared-with-placebo-in-participants-with-type-2-diabetes-on-a-stable-dose-of-semaglutide-or-tirzepatide-100585062","NCT06897475","A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide","A Parallel-Group Treatment, Phase 2, Double-Blind Study of Once-Weekly Subcutaneous LY3457263 Compared to Placebo in Participants With Type 2 Diabetes Mellitus on a Stable Dose of Semaglutide or Tirzepatide Who Failed to Achieve HbA1c Goal","Inclusion Criteria:\n\n* Have type 2 diabetes\n* Have HbA1c ≥7.5% to ≤10.5% at screening\n* Have a body mass index (BMI) of ≥27 kilograms per square meter (kg\u002Fm2) at screening\n* Have had a stable body weight for the three months prior to screening\n* On stable treatment dose of one of the following incretins for at least three months prior to screening:\n\n  * Injectable semaglutide (1 and 2 milligram (mg))\n  * Injectable tirzepatide (5, 7.5, 10, 12.5 and 15 mg)\n\nExclusion Criteria:\n\n* Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar coma\n* Have a prior or planned surgical treatment for obesity\n* Have any of the following cardiovascular conditions within three months prior to screening:\n\n  * acute myocardial infarction\n  * cerebrovascular accident (stroke)\n  * unstable angina, or\n  * hospitalization due to congestive heart failure\n* Have used insulin to control blood glucose within the past year (short-term use allowed)\n* Current use of prohibited oral antihyperglycemic medication (OAM) (including but not limited to, Dipeptidyl Peptidase IV Inhibitors (DPP-4i) and meglitinides) may be randomized if the prohibited OAM treatment was discontinued at least 3 months prior to screening\n\n  * If participant has been on stable doses (for at least three months) of up to three permitted OAMs (limited to metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors, alpha-glucosidase inhibitors, sulfonylurea, and\u002For thiazolidinediones (TZD), they are permitted to participate in the study\n* Have taken any medications or alternative remedies for weight loss within three months prior to screening",{"count":117,"type":22},240,[119],"PHASE2","The purpose of this study is to measure the change in hemoglobin A1c (HbA1c) with LY3457263 compared with placebo in participants with type 2 diabetes who are not at HbA1c goal when treated with a stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months.",[28],[123,124],"Obesity","Overweight",{"date":47,"type":48},{"date":127,"type":48},"2025-03-28",{"date":129,"type":22},"2027-01",{"name":131,"class":77},"Eli Lilly and Company",60,{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":141,"minAge":142,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":146,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":159,"leadSponsor":161,"locationsCount":56},"100652818","metformin-dapagliflozin-effects-on-igf-1-in-male-t2dm-with-masld-100652818","NCT07778719","Metformin-Dapagliflozin Effects on IGF-1 in Male T2DM With MASLD","Effects of Metformin Combined With Dapagliflozin on Serum IGF-1 Levels in Male Patients With Type 2 Diabetes Mellitus and Metabolic Dysfunction-Associated Steatotic Liver Disease","MDEITM","Inclusion Criteria:\n\n1. Males aged 30-60 years;\n2. Meeting the WHO diagnostic criteria for type 2 diabetes mellitus, with HbA1c levels between 7.0% and 10.0%;\n3. Having received a stable dose of metformin (≥1500 mg\u002Fday or the maximum tolerated dose) as monotherapy for at least 8 weeks;\n4. Meeting the diagnostic criteria for MASLD: Controlled Attenuation Parameter (CAP) value ≥248 dB\u002Fm detected, with the presence of at least one cardiometabolic risk factor;\n5. No prior use of SGLT2 inhibitors, insulin secretagogues, insulin, or GLP-1 receptor agonists;\n6. Willing to participate voluntarily and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Type 1 diabetes mellitus or other specific types of diabetes;\n2. Weekly alcohol intake exceeding 210g for males;\n3. Concomitant chronic liver diseases (viral hepatitis, autoimmune liver disease, Wilson's disease, hemochromatosis, etc.);\n4. Known pituitary or hypothalamic diseases affecting the GH-IGF-1 axis;\n5. Previous or current use of GH preparations or IGF-1 preparations;\n6. Baseline estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73m²;\n7. Previous diagnosis of cardiovascular diseases (coronary heart disease, stroke, heart failure) or severe liver diseases (decompensated cirrhosis);\n8. Active malignant tumors;\n9. Allergy to dapagliflozin or similar drugs;\n10. Use of medications affecting IGF-1 levels (such as oral estrogens, high-dose glucocorticoids) within the past 3 months;\n11. Diabetic ketoacidosis, severe infection, or surgical stress within 1 month prior to enrollment.","MALE","30 Years","60 Years",{"count":145,"type":22},84,[25],"This is a 3-month, single-center, prospective, randomized, parallel-controlled, open-label trial investigating the effects of metformin combined with dapagliflozin on serum IGF-1 levels in male patients with type 2 diabetes mellitus (T2DM) and metabolic dysfunction-associated steatotic liver disease (MASLD). A total of 84 eligible male patients (aged 30-60 years, HbA1c 7.0%-10.0%, CAP ≥248 dB\u002Fm, on stable metformin monotherapy for ≥8 weeks) will be randomized 1:1 to either continue metformin alone or receive metformin plus dapagliflozin 10 mg\u002Fday for 12 weeks. The primary endpoint is the change in serum IGF-1 from baseline to 3 months between groups. Secondary endpoints include changes in hepatic steatosis (CAP), liver stiffness (LSM), FIB-4 index, metabolic parameters, and safety outcomes. The study aims to determine whether adding dapagliflozin to metformin can restore the suppressed GH-IGF-1 axis and provide mechanistic insights into its hepatoprotective effects.",[28,149],"Metabolic Dysfunction-Associated Steatotic Liver Disease",[151,152,153,154,149],"Dapagliflozin","Metformin","Serum IGF-1","Type 2 Diabetes Mellitus","NOT_YET_RECRUITING","2026-08-19",{"date":47,"type":48},{"date":52,"type":22},{"date":160,"type":22},"2027-12-11",{"name":162,"class":55},"The 95th Hospital of Putian，Putian, Fujian, China",{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":173,"briefSummary":175,"conditions":176,"keywords":180,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":56},"100652893","phase-1-alpelisib-challenge-test-act-100652893","NCT07778524","Alpelisib Challenge Test (ACT)","Alpelisib Challenge Test (ACT) for Assessment of Pancreatic β-Cell Reserve, Pilot & Feasibility Study","Inclusion Criteria:\n\n* Adults aged 18-70 years\n* Able to understand wrifen and spoken English and\u002For Spanish\n* Body mass index of 18-45 kg\u002Fm2 (or 18-42 kg\u002Fm2 for those of Asian ancestry)\n\n  * For Lean group: BMI 18.0-24.9 kg\u002Fm2 (or 18.0-22.9 kg\u002Fm2 for those of Asian ancestry)\n  * For Overweight group: BMI 25.0-29.9 kg\u002Fm2 (or 23.0-27.4 kg\u002Fm2 for those of Asian ancestry)\n  * For Obesity group: BMI 30.0-45.0 kg\u002Fm2 (or 27.5-42 kg\u002Fm2 for those of Asian ancestry)\n\nExclusion Criteria:\n\n* Inability to provide informed consent in English or Spanish\n* Unwillingness to fast (except water) for up to 18 hours\n* Unwillingness not to get out of bed and to use bedpan\u002Furinal to void for up to 15 hours\n* Documented weight change of ≥ 5.0% of baseline within the previous 3 months\n* Abnormal blood pressure\n\n  * Systolic blood pressure \\\u003C 90 mm Hg or \\> 160 mm Hg, and\u002For\n  * Diastolic blood pressure \\\u003C 55 mm Hg or \\> 100 mm Hg\n* Abnormal resting heart rate \\\u003C 55 bpm or ≥ 110 bpm\n\n  * Sinus tachycardia that has been extensively worked up and considered benign by the recruit's personal physician may be permitted at the PI's discretion\n  * Sinus bradycardia between heart rates of 45 and 54 bpm may be permitted at the PI's discretion if in a clinically appropriate setting (e.g., toned athlete, taking beta blockers)\n* Abnormal (i.e., non-regular) heart rhythm detected on physical exam\n* Abnormal screening serum electrolytes judged by the PI to be potentially clinically significant\n* Liver function abnormalities (either of the following)\n\n  * Transaminases (AST or ALT) \\> 3.0 x the upper limit of normal\n  * Total bilirubin \\> 1.25 x the upper limit of normal\n* Laboratory evidence of diabetes mellitus:\n\n  * Hemoglobin A1c ≥ 6.5%, and\u002For\n  * Fasting plasma glucose ≥ 126 mg dL-1\n* Positive qualitative β-hCG (i.e., pregnancy test) in women of childbearing potential\n* Women currently pregnant\n* Women currently breastfeeding\n* History of having met any of the American Diabetes Association's definitions of diabetes mellitus (i.e., overt diabetes):\n\n  * Hemoglobin A1c ≥ 6.5%, or rapid rise in documented HbA1c values causing clinical concern for evolving insulin deficiency\n  * Plasma glucose ≥ 126 mg\u002FdL after 8-h fast\n  * Plasma glucose of ≥ 200 mg\u002FdL at 2 h after ingestion of a 75-g glucose load\n  * Random plasma glucose ≥ 200 mg\u002FdL associated with typical hyperglycemic symptoms, diabetic ketoacidosis, or hyperglycemic-hyperosmolar state\n* History of gestational diabetes mellitus within the previous 5 years\n* Use of most antidiabetic medications within the 90 days prior to screening\n\n  * Exceptions: thiazolidinediones, sulfonylureas, meglitinides, DPP4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, amylin mimetics, acarbose, insulin\n  * Metformin is acceptable provided that recruits meet all of the inclusion criteria at screening\n* Clinical concern for absolute insulin deficiency (e.g., type 1 diabetes, pancreatic disease)\n* Cardiovascular diseases (N.B. uncomplicated hypertension is not exclusionary)\n\n  * Atherosclerotic cardiovascular disease\n  * Stable or unstable angina\n  * Myocardial infarction\n  * Ischaemic or hemorrhagic stroke\n  * Peripheral arterial disease (claudication)\n  * Use of dual antiplatelet therapy (aspirin + P2Y12 inhibitor)\n  * History of percutaneous coronary intervention\n  * Congestive heart failure (NYHA Class ≥ 2)\n  * Severe valvular heart disease (e.g., aortic stenosis)\n  * Pulmonary hypertension\n* Advanced or severe liver disease, including but not limited to:\n\n  * Advanced liver fibrosis, as determined by non-invasive testing\n  * Cirrhosis of any etiology\n  * Autoimmune hepatitis or other rheumatologic disorder affecting the liver\n  * Biliopathy (e.g., progressive sclerosing cholangitis, primary biliary cholangitis)\n  * Chronic liver infection (e.g., viral hepatitis, parasitic infestation)\n  * Hepatocellular carcinoma\n  * Infiltrative disorders (e.g., sarcoidosis, hemochromatosis, Wilson disease)\n* Psychiatric diseases causing functional impairment that:\n\n  * Are or have been decompensated within 1 year of screening, and\u002For\n  * Require use of anti-dopaminergic antipsychotic drugs associated with significant weight gain\u002Fmetabolic dysfunction (e.g., clozapine, olanzapine)\n* Venous thromboembolic disease (deep vein thrombosis or pulmonary embolism) or any required use of therapeutic anticoagulation\n* Bleeding disorders, including due to anticoagulation, or significant anemia (see above)\n* Active malignancy, or hormonally active benign neoplasm, except allowances for:\n\n  * Non-melanoma skin cancer\n  * Differentiated thyroid cancer (AJCC Stage I only)\n* Clinical concern for increased risk of volume overload, including due to medications and\u002For heart\u002Fliver\u002Fkidney problems, as listed above\n* Use of certain medications currently or within 30 days prior to screening:\n\n  * Prescribed medications used for any of the indications in the preceding list of excluded conditions, or their use within 30 d prior to screening, except allowances for:\n\n    * Use of drugs prescribed for indications other than the exclusionary diagnoses\u002Fpurposes listed above (e.g., ACEi\u002FARB used for uncomplicated hypertension rather than for congestive heart failure, etc.)\n    * Note, as above, that antidiabetic drugs except metformin within 30 d of screening are excluded\n  * Oral or parenteral corticosteroids (at greater than prednisone 5 mg daily, or equivalent) for more than 3 days within the previous 30 days; topical and inhaled formulations are permitted\n* History of certain weight-loss (bariatric) surgery, including:\n\n  * Roux-en-Y gastric bypass\n  * Biliopancreatic diversion\n  * Restrictive procedures (lap band, sleeve gastrectomy) performed within the past 6 months\n* Clinical concern for alcohol overuse based on chart review and\u002For by recruit's report of more than 14 standard drinks per week for males or more than 7 standard drinks per week for females\n* Regular tobacco use (smoking more than 1 cigarette per week) or regular nicotine vaping (daily)\n* Clinical concern for use of illicit drugs other than marijuana or lawfully prescribed medications based on recruit's report, chart review, and point-of-care urine drug test at screening\n* History of or ongoing febrile illness within 14 days of screening\n* Any other disease or condition or laboratory value that, in the opinion of the investigator, would place the participant at an unacceptable risk and\u002For interfere with the analysis of study data.\n* Known allergy\u002Fhypersensitivity to any component of the medicinal product formulations (including soy, cow dairy, or gluten), other biologics, venipuncture materials, plastics, adhesive or silicone, or ongoing clinically important allergy\u002Fhypersensitivity as judged by the investigator.\n* Concurrent enrollment in another clinical study of any investigational drug\u002Fbiologic therapy within 5 half-lives of an investigational agent or biologic.","70 Years",{"count":172,"type":22},15,[174],"PHASE1","The goal of this study is to test a potentially easier method for measuring how much insulin a person is capable of producing than the current gold-standard method, the \"hyperglycemic clamp.\" Participants will come in for a two-day (overnight) visit in which they will first undergo a \"hyperglycemic clamp,\" in which they receive an intravenous (into the vein) infusion of glucose (sugar) in order to measure the maximum amount of insulin their body produces in response. They will then consume a series of three standardized meals throughout the rest of the day. At 23:00, they will take a single dose of alpelisib, a drug that interferes within insulin's actions in the body. Then, the following morning, they will undergo a \"Mixed Meal Tolerance Test\" in which they consume a standardized liquid nutritional beverage and have blood drawn periodically before and during the test.",[177,28,178,179],"Insulin Resistance","Obesity & Overweight","Healthy Adult Participants",[181,182,183,123,124,184],"Insulin resistance","Type 2 diabetes","Hyperinsulinemia","Healthy volunteers","2026-08-18",{"date":47,"type":48},{"date":188,"type":22},"2026-09-01",{"date":190,"type":22},"2028-08-31",{"name":192,"class":55},"Columbia University",{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":17,"sex":18,"minAge":201,"maxAge":170,"enrollmentInfo":202,"targetDuration":4,"studyType":204,"phases":4,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":108},"100649081","specimen-and-data-collection-in-south-carolina-medicaid-enrolled-patients-with-type-2-diabetes-t2d-and-metabolically-healthy-controls-100649081","NCT07731399","Specimen and Data Collection in South Carolina Medicaid-Enrolled Patients With Type 2 Diabetes (T2D) and Metabolically Healthy Controls","An Observational Clinical Research Study Assembling and Analyzing Highly Complex, Multi-dimensional Molecular and Clinical Data With a Focus on High-risk Diabetes Patients in South Carolina, in Support of the Biomedical Research Initiative for Scientific Knowledge (BRISK)","BRISK 2","INCLUSION CRITERIA:\n\nAll Participants:\n\n* 40 to 70 years of age (inclusive) at enrollment\n* Enrolled as Medicaid recipients\n* Ability to provide informed consent and authorization for release of relevant protected health information or personal data\n* Ability to provide a blood sample(s) of up to 70 mL and other required biospecimens, including genetic samples.\n\nT2D Group:\n\n• Current diagnosis of Type 2 diabetes OR a blood level of hemoglobin A1c equal to or greater than 6.5% at any time within the past 12 months\n\nControl Group:\n\n* Blood level of hemoglobin A1c less than or equal to 5.6% at time of enrollment\n* No diagnosis of Type 2 diabetes\n\nEXCLUSION CRITERIA:\n\n* Pregnancy at time of enrollment (by self-report of pregnancy status)\n* Lack of fluency in spoken and written English\n* Type 1 diabetes or any other type of diabetes besides Type 2 diabetes\n* Active cancer diagnosis or cancer that achieved complete remission within three (3) years prior to enrollment, other than non-melanoma skin cancer (e.g. malignant basal cell neoplasm of skin and\u002For squamous cell carcinoma of skin)\n* Major Adverse Cardiovascular Events within two (2) years prior to enrollment\n* Chronic Obstructive Pulmonary Disease\n* Cognitive impairment or neurodegenerative diseases (e.g., Alzheimer's disease, dementia, multiple sclerosis, Parkinson's disease, etc.)\n* Pancreatitis or other diseases of the pancreas (besides diabetes)\n* The participant is, in the opinion of the investigator, unlikely to be able to complete all study requirements","40 Years",{"count":203,"type":22},1200,"OBSERVATIONAL","The primary purpose of this study is to use multiomic data in combination with clinical assessments, electronic health records, cognitive and mood assessments, wearable technologies and lifestyle\u002Fbehavioral data to identify data elements or combinations of data elements with strong positive or negative correlation to CKD diagnosis and\u002For progression in Type 2 Diabetes (T2D) patients. Achieving this aim will allow researchers and physicians to significantly improve the prediction of health trajectories of and formulate novel strategies to potentially prevent, treat or reverse T2D. South Carolina Medicaid-enrolled patients diagnosed with T2D and a smaller subset of non-T2D SC Medicaid patients may participate in this study. Participants who complete required procedures will be compensated for their time and transportation, may keep their study-provided Fitbit device to help maintain their healthcare improvement journey, and will have a personal Certified Diabetes Educator to consult and assist with managing their diabetes diagnosis.",[28,207],"Healthy (Controls)","2026-08-17",{"date":185,"type":48},{"date":211,"type":22},"2026-08",{"date":213,"type":22},"2029-10",{"name":215,"class":55},"Guardian Research Network, Inc.",{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":18,"minAge":224,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":23,"phases":227,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":241,"leadSponsor":243,"locationsCount":56},"100630237","phase-4-exercise-and-diabetes-interventions-to-improve-brain-health-in-older-adults-with-type-2-diabetes-100630237","NCT07485062","Exercise and Diabetes Interventions to Improve Brain Health in Older Adults With Type 2 Diabetes","Metabolic Optimization and Training InterVentions for Aging and Type 2 Diabetes to Enhance Cognition: the MOTIVATE Study","MOTIVATE","Inclusion Criteria:\n\n1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.\n2. Community-dwelling\n3. Male or female\n4. Age ≥ 65 at the time of signing informed consent\n5. Glycated hemoglobin levels of ≥7% (i.e., A1c levels high enough to see intervention-related changes and increase eligibility for recruitment, but can exercise safely)\n6. Eligible for the Ontario Drug Benefit (inadequate glycemic control and on max tolerated dose of metformin or metformin contraindicated or inappropriate)\n7. Score \\>24\u002F30 on the Mini-Mental State Exam (MMSE)\n8. Score \\>6\u002F8 on the Lawton Instrumental Activities of Daily Living Scale (IADL)\n9. Have visual acuity of \\>20\u002F40 with or without corrective lenses\n10. Speak and understand English fluently\n11. Complete the Physical Activity Readiness Questionnaire (PAR-Q+) and obtain physician clearance to start a supervised exercise program\n12. Comfortable with a blood draw\n13. Not currently engaging in structured resistance exercise more than once per week\n\nExclusion Criteria:\n\n1. Have a medical condition for which semaglutide or exercise is contraindicated\n2. Use of a GLP-1 receptor agonist in the past 6 months (i.e., offers removal of Semaglutide from the system as it has a half-life of around 1 week; thus, 8-10 weeks are required for a washout.\n\n3\\) Have engaged regularly (\\>1\u002Fweek) in aerobic or RE within the past 6 months 4) Have a neurodegenerative disease (i.e., dementia) or psychiatric condition 5) Have had untreated depression in the past 6 months (6) Have experienced a recent vascular incident (i.e., stroke, myocardial infarction in the last 6 months.) (7) Have severe peripheral neuropathy, an active foot wound, or severe musculoskeletal\u002Fjoint disease (8) Active or untreated retinopathy (9) Taking psychotropic medications (excluding those for the treatment of depression)","65 Years",{"count":226,"type":22},164,[228],"PHASE4","Type 2 diabetes and low levels of physical activity are associated with an increased risk of cognitive decline in older adults. Improving blood sugar control and engaging in regular exercise may help support brain health and physical function in this population.\n\nThe MOTIVATE study is a randomized clinical trial designed to examine the effects of supervised exercise and diabetes treatment with semaglutide, alone or in combination, on cognitive function, physical health, and brain-related outcomes in older adults with Type 2 diabetes. Participants will be assigned to one of four study groups involving exercise training, control exercise, semaglutide treatment, or standard diabetes care.\n\nParticipants will complete supervised exercise sessions three times per week for 32 weeks, with some participants also receiving weekly semaglutide injections for 16 weeks. Assessments will include cognitive testing, physical and functional measures, blood-based metabolic markers, and brain imaging. This study aims to improve understanding of how exercise and diabetes treatments may support brain health in older adults with Type 2 diabetes.",[28,231],"Cognitive Decline in Older Adults",[233,234,235,236,237,238,28],"Exercise Training","Semaglutide","Brain Health","Cognitive Function","Older Adults","Physical Activity",{"date":45,"type":48},{"date":188,"type":22},{"date":242,"type":22},"2029-05-01",{"name":244,"class":55},"Western University, Canada",{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":23,"phases":255,"briefSummary":256,"conditions":257,"keywords":258,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":56},"100651934","prodiap---patient-reported-outcomes-in-general-practice-among-people-with-type-2-diabetes-100651934","NCT07767331","PRODIAP - Patient-reported Outcomes in General Practice Among People With Type 2 Diabetes","PRODIAP - Patient-Reported Outcomes in General Practice Among People With Type 2 Diabetes","PRODIAP","Inclusion Criteria:\n\n* type 2 diabetes\n* able to understand and answer a Danish questionnaire\n\nExclusion Criteria:\n\n* none",{"count":254,"type":22},2000,[25],"In Denmark, around 327,000 diabetes consultations take place annually in general practice, but these often fail to fully include patients' experiences, values, and needs. Research, mainly among people with type 1 diabetes, suggests that the use of Patient Reported Outcomes (PROs) can enhance patient engagement and consultation quality. Yet, little is known about the effect of using PROs in type 2 diabetes (T2D) care in general practice. This project, PRODIAP (Patient-reported outcomes in general practice among people with type 2 diabetes) aims to investigate whether the use of a diabetes-specific PRO questionnaire can improve care quality and support more individualised consultations for people with T2D. PRODIAP is tailored to general practice, adapted from hospital PRO tools, and pilot testing showed promising feasibility and acceptability.\n\nThis project applies a mixed-methods design with two sub-studies:\n\n1. A pragmatic, cluster-randomised controlled trial in 30 general practices (N≈2000 patients) evaluating PRODIAP's effect on perceived care quality with patient perceived quality of care (PACIC) as primary outcome.\n2. A qualitative study using observations and interviews to explore how PRODIAP shapes the consultation from both patient and professional perspectives.\n\nThe project group has established a national collaboration with general practitioners, researchers and stakeholders from all five Danish region, supporting the feasibility of this study. Findings are expected to improve diabetes care in general practice and inform management of other chronic conditions. Findings are expected to improve diabetes care in general practice and provide transferable knowledge for other chronic conditions.",[28],[259,260,261],"Patient Reported Outcome (PRO)","General Practice (GP)","Randomised controlled trial","2026-08-14",{"date":208,"type":48},{"date":265,"type":48},"2026-03-01",{"date":267,"type":22},"2028-02",{"name":269,"class":55},"University of Aarhus",{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":17,"sex":18,"minAge":170,"maxAge":278,"enrollmentInfo":279,"targetDuration":4,"studyType":23,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":284,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":108},"100614916","glycaemic-outcomes-with-whey-protein-in-ageing-100614916","NCT07285811","GLycaemic Outcomes With Whey Protein in ageING","Whey Protein Dose-response Effect on Daily Glycaemic Excursions in Very Old Individuals With Type 2 Diabetes","GLOWING","* Male or female\n* 70-90 years old\n* Type 2 Diabetes (confirmed with glycated haemoglobin (HbA1c) \\>6.5% in clinic or in SportExR)\n* Stable body mass (body mass index (BMI) ≤40kg\u002Fm2)\n* Generally healthy, assessed via a General Health Questionnaire (GHQ)\n* Some residual beta-cell activity (confirmed with urine test on induction)\n* Normal or moderately increased albuminuria (needs to be below 300mg\u002Fg)\n* Normal, mildly or moderately decreased glomerular filtration rate (GFR) (needs to be above 45ml\u002Fmin\u002F1.732).\n* Able and willing to attend SportExR a total of 5 times: 1 induction and 2 testing visits and 2 return check-up visits.\n\nExclusion Criteria:\n\n* \\\u003C70 years old and over 90 years of age\n* Currently on fast-acting insulin therapy (i.e., Humalog)\n* Confirmed uncontrolled diabetes (HbA1C \\>10% or 85mmol\u002Fmol).\n* Currently on GLP-1 therapy\n* Habitual smoker or vaper\n* Veganism\n* Lactose or dairy intolerance\n* Coeliac or gluten intolerance\n* History of gastrointestinal disease\n* Experienced a hyperglycaemic or hypoglycaemic event requiring treatment in the past 12 months\n* Recent Ischemic stroke (\\\u003C3 months).\n* Use of anticoagulants (e.g. warfarin, rivaroxaban)\n* Considered unwilling or unable to comply with the study protocol requirements by the research team","90 Years",{"count":280,"type":22},32,[25],"The goal of this placebo-controlled, partial crossover design study is to identify the impact of consuming whey protein before meals on free-living glucose control in older adults living with type 2 diabetes.\n\nThe primary specific objective is to determine the effect of a thrice daily whey protein pre-meal supplementation at two doses, on glucose excursions over a 7-day free-living period in adults aged 70-90 years of age, living with type 2 diabetes, compared with a non-protein placebo.\n\nParticipants will consume the whey protein and placebo for 7 days each, before each meal. All participants will consume the placebo and one of two doses of whey protein, in a randomised order.",[28],{"date":185,"type":48},{"date":286,"type":48},"2026-01-02",{"date":288,"type":22},"2026-12",{"name":290,"class":55},"University of Birmingham",{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":298,"minAge":19,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":23,"phases":301,"briefSummary":302,"conditions":303,"keywords":306,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":56},"100636063","nourish---a-healthcare-community-partnership-to-improve-nutrition-for-optimal-glycemic-control-and-pregnancy-outcomes-with-pregestational-diabetes-100636063","NCT07560813","NOURISH - A Healthcare-community Partnership to Improve Nutrition for Optimal Glycemic Control and Pregnancy Outcomes With Pregestational Diabetes","NOURISH","Inclusion criteria:\n\n* Pregnant with singleton or twin pregnancy\n* Gestational age \\>8+0 to ≤22+6 weeks at enrollment by project EDD\n* Age ≥ 18 years.\n* Type 1 or 2 diabetes.\n* Screen positive for food insecurity based on answering \"Often\" or \"Sometimes\" true to either of the two questions on the USDA Hunger Vital Sign screening questions (within 12 months of enrolling in prenatal care).\n* English or Spanish speaking.\n* Willing to participate in Mid-Ohio Farmacy program and able to provide a home address to which food delivery can be provided by the Mid-Ohio Food Collective.\n* Hemoglobin A1c criteria:\n\n  * If not taking glucagon-line peptide-1 (GLP-1) or sodium-glucose co-transporter 2 (SGLT2) medication within 12 months of enrolling in prenatal care, A1c ≥6.5% during this time period.\n  * If taking GLP-1 or SGLT2 medication within 12 months of enrolling in prenatal care, A1c≥6.5% during the 12 months prior to initiation of these medications.\n\nExclusion Criteria\n\n* Involuntarily confined or detained.\n* Considered as having a diminished decision-making capacity.","FEMALE",{"count":300,"type":22},174,[25],"Nutrition insecurity (inclusive of food insecurity + poor diet quality) is a fundamental social need that must be addressed to improve treatment and health outcomes for high-risk pregnant women with pregestational type 1 and 2 diabetes, poor glucose control, and food insecurity for whom a healthy diet is critical. The NOURISH trial will provide evidence of a scalable, integrated, and theory-based healthcare-community partnership that includes weekly nutritious produce home delivery, monthly clinic-integrated diabetes, nutrition, and culinary group education, and continuous social needs assessment and support to improve glucose control and pregnancy outcomes. Given the increasing burden and devasting consequences of nutrition insecurity among high-risk pregnant women with diabetes and unmet social needs, NOURISH-an innovative and sustainable healthcare-community partnership-will have significant public health benefit.",[28,304,305],"Type 1 Diabetes","Pregnancy, High Risk",[307,304,28,308,309,310],"Pregnancy","food insecurity","nutrition insecurity","social determinants of health","2026-08-12",{"date":262,"type":48},{"date":314,"type":48},"2026-07-06",{"date":316,"type":22},"2030-06-30",{"name":318,"class":55},"Ohio State University",{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":326,"enrollmentInfo":327,"targetDuration":4,"studyType":23,"phases":328,"briefSummary":329,"conditions":330,"keywords":333,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":108},"100462716","phase-4-quantifying-hepatic-mitochondrial-fluxes-in-humans-100462716","NCT05305287","Quantifying Hepatic Mitochondrial Fluxes in Humans","Quantitation of Hepatic Mitochondrial Fluxes in Humans With Nonalcoholic Fatty Liver Disease (NAFLD)","T2D with NAFL\n\nInclusion Criteria:\n\n* Confirmed T2D based on OGTT (2 h glucose ≥200 mg\u002Fdl).\n* Treated with diet, metformin, and\u002For sulfonylurea and in good general health determined by medical history, physical exam, and routine blood chemistries;\n* age = 18-80 years;\n* BMI = 25-40 kg\u002Fm2;\n* HbA1c = 7-10%; stable body weight (±4 pounds) over the preceding 3-months;\n* not taking any medication known to affect glucose metabolism other than antidiabetic medications.\n* Evidence of moderate\u002Fsevere fatty liver (steatosis; grade S2\u002FS3 on FibroScan corresponding to ≥10% fat on MRI-PDFF) and no\u002Fminimal hepatic fibrosis (grade F0\u002FF1 on FibroScan).\n\nExclusion Criteria:\n\n* Alcohol consumption \\>14 units\u002Fweek for women and \\>21 units\u002Fweek for men.\n* Liver cirrhosis (fibrosis stage 4).\n* Evidence of other forms of chronic liver disease, including alcoholic liver disease, hepatitis B and C, primary biliary cholangitis, suspected\u002Fproven liver cancer and any other liver disease other than NAFLD.\n* Type 1 diabetes and\u002For GAD positive subjects.\n* Subjects not drug naive or have been on metformin more than 3 months.\n* Presence of proliferative retinopathy.\n* Urine albumin excretion \\> 300 mg\u002Fday.\n* History of NY Class III-IV heart failure\n\nT2D with NASH\n\nInclusion Criteria:\n\n* Confirmed T2D based on OGTT (2 h glucose ≥200 mg\u002Fdl).\n* Treated with diet, metformin, and\u002For sulfonylurea and in good general health determined by medical history, physical exam, and routine blood chemistries;\n* age = 18-80 years;\n* BMI = 25-40 kg\u002Fm2;\n* HbA1c = 7-10%;\n* stable body weight (±4 pounds) over the preceding 3-months;\n* not taking any medication known to affect glucose metabolism other than antidiabetic medications.\n* Evidence of moderate\u002Fsevere fatty liver (steatosis; grade S2\u002FS3 on FibroScan corresponding to ≥10% liver fat on MRI-PDFF) and moderate\u002Fsevere hepatic fibrosis (grade F2\u002FF3 on FibroScan).\n\nExclusion Criteria:\n\n* Alcohol consumption \\>14 units\u002Fweek for women and \\>21 units\u002Fweek for men.\n* Liver cirrhosis (fibrosis stage 4).\n* Evidence of other forms of chronic liver disease, including alcoholic liver disease, hepatitis B and C, primary biliary cholangitis, suspected\u002Fproven liver cancer and any other liver disease other than NAFLD.\n* Type 1 diabetes and\u002For GAD positive subjects.\n* Subjects not drug naive or have been on metformin more than 3 months.\n* Presence of proliferative retinopathy.\n* Urine albumin excretion \\> 300 mg\u002Fday.\n* History of NY Class III-IV heart failure","80 Years",{"count":132,"type":22},[228],"In this study the investigators will quantitate hepatic mitochondrial fluxes in T2D patients with NAFL and NASH before and after 16-weeks treatment with the insulin sensitizer pioglitazone",[331,28,332],"Non-Alcoholic Fatty Liver Disease","Mitochondrial Metabolism Disorders",[334,335,182,181],"NAFLD","Mitochondria",{"date":208,"type":48},{"date":338,"type":48},"2022-11-01",{"date":340,"type":22},"2027-03-31",{"name":342,"class":55},"The University of Texas Health Science Center at San Antonio",{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":23,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":360,"locationsCount":56},"100614356","adaptive-dietary-intervention-adi-for-asian-americans-with-type-2-diabetes-100614356","NCT07278531","Adaptive Dietary Intervention (ADI) for Asian Americans With Type 2 Diabetes","Adaptive Dietary Intervention (ADI) Leveraging Continuous Glucose Monitoring for Asian Americans With Type 2 Diabetes","Inclusion Criteria:\n\n* Eligible participants (N=120; 60 Chinese Americans and 60 Vietnamese Americans)\n* Community-dwelling adults aged ≥ 18 with independent living;\n* Diagnosed with T2D;\n* Hb1Ac\\>7.0%\n* Self-identified as first- or second-generation Chinese or Vietnamese immigrants;\n* Able to communicate in English, Chinese, or Vietnamese. We will focus on Mandarin-, Cantonese- or English-speaking Chinese Americans because the two best-known and most-spoken variants of Chinese are Mandarin and Cantonese, who use the same writing system;\n* Have a smartphone, iPad, tablet, or Apple watch\n\nExclusion Criteria:\n\n* Taking hypoglycemia agents (e.g., insulin and sulfonylureas) with the major side effect of hypoglycemia that need close monitoring the occurrence of hypoglycemia to adjust\u002Freduce medications to avoid future hypoglycemia.\n* Taking medications that impede weight loss (e.g., prednisone) within the last 3 months.\n* Currently pregnant, breastfeeding, or contemplating pregnancy within the next 6 months.\n* Have serious physical complications (e.g., severe neuropathy cardiovascular disease, COPD\u002Femphysema, osteoarthritis, or stroke) or mental disease (e.g., schizophrenia, bipolar disorder, manic depressive illness, severe depression, or active substance abuse).\n* Have conditions that restrict diet, such as severe gastroparesis, ulcers, or food allergies. These conditions may need special dietary intervention.\n* Undergoing treatment for cancer, as cancer treatment may impact the outcome of glucose changes.\n* Have marked renal impairment (eGRF\\\u003C45; CKD-3b), as renal impairment may needs special dietary intervention and they also may impact glucose changes.\n* Are taking psychotropic medications that raise blood glucose (e.g., atypical antipsychotics).\n* Are prior or current CGM users including both Dexcom and FreeStyle Libre and plan to continuously use these CGMs in the next 6 months.\n* Are participating in another T2D intervention study.",{"count":78,"type":22},[25],"The investigators will examine the feasibility, acceptability, and effect of an adaptive dietary intervention over 24 weeks (12-week intervention, 12-week follow-up) among Asian Americans with Type 2 diabetes. Participants (N=120; 60 Chinese Americans and 60 Vietnamese Americans) will be 2:1 randomized to one of two arms: adaptive dietary intervention or standard of care (SC). The intervention will begin with continued glucose monitoring (CGM) use only during weeks 0-4. At week 4, participants who achieve the glycemic control goal (at least an 8% increase in time in range \\[TIR\\] from baseline) will continue with the CGM alone during weeks 4-12 (\"CGM Alone\"); otherwise, culturally and linguistically adapted glucose excursion minimization (GEM) will be augmented with CGM (\"CGM-GEM\").",[28],"2026-08-11",{"date":356,"type":48},"2026-08-13",{"date":358,"type":22},"2027-02",{"date":190,"type":22},{"name":361,"class":55},"NYU Langone Health",{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":17,"sex":18,"minAge":369,"maxAge":370,"enrollmentInfo":371,"targetDuration":4,"studyType":23,"phases":373,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":56},"100592440","acute-exercise-and-endogenous-glucose-production-in-type-2-diabetes-implications-for-glycemic-control-and-treatment-of-hepatic-steatosis-100592440","NCT06993454","Acute Exercise and Endogenous Glucose Production in Type 2 Diabetes: Implications for Glycemic Control and Treatment of Hepatic Steatosis","ACELERATE-P","Inclusion criteria for individuals with T2D and elevated liver fat ≥5.6%\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or (pre-menopausal) female, aged 25-55 years\n4. Body mass index (BMI) between 25 and 45 kg\u002Fm2\n5. Sedentary (1 day or less per week of structured exercise)\n6. Type 2 diabetes mellitus: HbA1c ≥7.5%\n7. Liver fat ≥5.6% based on MRI\n8. Weight stable (± 2 kg) for prior 3 months\n\nInclusion criteria for lean, healthy controls\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or (pre-menopausal) female, aged 25-55 years\n4. Body mass index (BMI) between 18.5 and 27.5 kg\u002Fm2\n5. Normal liver fat (FibroScan CAP \\\u003C249dB\u002Fm, \\\u003C5.6% liver fat based on MRI)\n6. Weight stable (± 2 kg) for prior 3 months\n7. Active (≥3 day\u002Fweek of structured exercise)\n\nExclusion Criteria\n\n1. Exclusion criteria for individuals with T2D and elevated liver fat ≥5.6% Currently taking insulin, incretin mimetics, and\u002For thiazolidinediones\n2. Any change in glucose-lowering medications within the previous three months.\n3. Inability to stop any medications which interfere with glucose metabolism for visits 4 and 7.\n4. Resting blood pressure ≥ 160\u002F100 mm Hg\n5. Triglycerides ≥ 500 mg\u002FdL\n6. Any renal, cardiac, liver, lung, or neurological disease that in the opinion of the principal investigator would compromise participant safety or the participants' ability to complete the exercise protocol\n7. Any significant disease or unstable medical condition (i.e., coronary heart disease, chronic renal failure, chronic hepatic disease, severe pulmonary disease)\n8. Presence of clinically significant abnormalities on electrocardiogram (ECG) that is a contra-indication to exercise testing\n9. Cancer (active malignancy with or without concurrent chemotherapy; except for basal cell carcinoma)\n10. Pregnancy during the previous 6 months, lactating, or planned pregnancy in the next 6 months\n11. Post- or peri-menopausal women\n12. Partial and\u002For full hysterectomy (self-report)\n13. Use of drugs known to affect energy metabolism or body weight: including, but not limited to orlistat, sibutramine, ephedrine, phenylpropanolamine, corticosterone, etc\n14. Hyperthyroidism including those with normal TSH (0.35-4.5) on pharmacological treatment; individuals with hypothyroidism may be referred to their primary care provider for evaluation and retested; any medication change for hypothyroidism must be stable for ≥3 months prior to retesting\n15. Current treatment with blood thinners or anti-platelet medications that cannot be safely stopped for testing procedures\n16. New onset (\\\u003C3 months on a stable regime) hormone replacement therapy\n17. Current use of beta-adrenergic blocking agents\n18. Major surgery on the abdomen, pelvis, or lower extremities within previous 3 months\n19. Previous bariatric or other surgery for obesity\n20. Abnormal blood count\u002Fanemia (hemoglobin \\\u003C12 g\u002Fdl in men or 11 g\u002Fdl in women; Hct \\\u003C34%), blood transfusion or blood donation within the last 2 months\n21. Current smokers (smoking within the past 3 months prior to screening visit, including any\u002Fall tobacco products)\n22. Current drug or alcohol abuse\u002Fdependence, or positive urine toxicology screen\n23. Alcohol consumption \\>7 drinks per week for women or 14 drinks per week for men or history of binge drinking (≥5 drinks for males or 4 drinks for females in a 2-hour period more than once per month)\n24. Metal implants (pacemaker, aneurysm clips) based on investigator's judgment at screening\n25. Not physically capable of performing the exercise required of the study protocols\n26. Unable to participate in Magnetic Resonance Imaging (MRI) assessments due to physical limitations of equipment tolerances (e.g. MRI bore size) based on investigator's judgment at screening.\n27. Unable to tolerate MRI or claustrophobia.\n28. Diagnosed psychotic or psychiatric conditions prohibiting adherence to study protocol; hospitalization for any psychotic or psychiatric condition within one year\n29. Self-reported chronic, active, or latent infection requiring chronic antibiotic or anti-viral treatment; Human Immunodeficiency Virus (HIV); active hepatitis B or C undergoing antiviral therapy\n30. Unable or unwilling to communicate with staff or to provide written informed consent\n\nExclusion criteria for lean, healthy controls\n\n1. Currently taking insulin, injectable incretin mimetics, and\u002For thiazolidinediones\n2. Taking glucose-lowering medications\n3. HbA1c ≥ 5.7%; pre-diabetes, type 2 diabetes, or type 1 diabetes\n4. Resting blood pressure ≥ 160\u002F100 mm Hg\n5. Triglycerides ≥ 500 mg\u002FdL\n6. Any renal, cardiac, liver, lung, or neurological disease that in the opinion of the principal investigator would compromise participant safety or the participants' ability to complete the exercise protocol\n7. Any significant disease or unstable medical condition (i.e., coronary heart disease, chronic renal failure, chronic hepatic disease, severe pulmonary disease)\n8. Presence of clinically significant abnormalities on electrocardiogram (ECG) that is a contra-indication to exercise testing\n9. Cancer (active malignancy with or without concurrent chemotherapy; except for basal cell carcinoma)\n10. Pregnancy during the previous 6 months, lactating, or planned pregnancy in the next year\n11. Post- or peri-menopausal women\n12. Partial and\u002For full hysterectomy (self-report)\n13. Use of drugs known to affect energy metabolism or body weight: including, but not limited to orlistat, sibutramine, ephedrine, phenylpropanolamine, corticosterone, etc\n14. Hyperthyroidism including those with normal TSH (0.35-4.5) on pharmacological treatment; individuals with hypothyroidism may be referred to their primary care provider for evaluation and retested; any medication change for hypothyroidism must be stable for ≥3 months prior to retesting\n15. Current treatment with blood thinners or anti-platelet medications that cannot be safely stopped for testing procedures\n16. New onset (\\\u003C3 months on a stable regime) hormone replacement therapy\n17. Current use of beta-adrenergic blocking agents\n18. Major surgery on the abdomen, pelvis, or lower extremities within previous 3 months\n19. Previous bariatric or other surgery for obesity\n20. Increased liver function tests (AST\u002FALT\u002FGGT\u002For alkaline phosphatase greater than 2.5 times the upper limit of normal)\n21. Abnormal blood count\u002Fanemia (hemoglobin \\\u003C12 g\u002Fdl in men or 11 g\u002Fdl in women; Hct \\\u003C34%), blood transfusion or blood donation within the last 2 months\n22. Current smokers (smoking within the past 3 months prior to screening visit, including any\u002Fall tobacco products)\n23. Current drug or alcohol abuse\u002Fdependence, or positive urine toxicology screen\n24. Alcohol consumption \\>7 drinks per week for women or 14 drinks per week for men or history of binge drinking (≥5 drinks for males or 4 drinks for females in a 2-hour period more than once per month)\n25. Metal implants (pacemaker, aneurysm clips) based on investigator's judgment at screening\n26. Not physically capable of performing the exercise required of the study protocols\n27. Unable to participate in Magnetic Resonance Imaging (MRI) assessments due to physical limitations of equipment tolerances (e.g. MRI bore size) based on investigator's judgment at screening.\n28. Unable to tolerate MRI or claustrophobia.\n29. Diagnosed psychotic or psychiatric conditions prohibiting adherence to study protocol; hospitalization for any psychotic or psychiatric condition within one year\n30. Self-reported chronic, active, or latent infection requiring chronic antibiotic or anti-viral treatment; Human Immunodeficiency Virus (HIV); active hepatitis B or C undergoing antiviral therapy\n31. Unable or unwilling to communicate with staff or to provide written informed consent","25 Years","55 Years",{"count":372,"type":22},12,[25],"The overall aim of this study is to investigate the effects of exercise on the amount of glucose that is made by the liver in people with and without Type 2 diabetes (T2D) and hepatic steatosis (fatty liver).",[28,376],"Hepatic Steatosis","2026-08-10",{"date":311,"type":48},{"date":380,"type":48},"2025-04-25",{"date":382,"type":22},"2028-12",{"name":384,"class":55},"AdventHealth Translational Research Institute",{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":18,"minAge":392,"maxAge":393,"enrollmentInfo":394,"targetDuration":4,"studyType":23,"phases":396,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":407},"100572888","phase-3-a-study-of-dulaglutide-ly2189265-30-mg-and-45-mg-in-pediatric-participants-with-type-2-diabetes-mellitus-award-peds-plus-100572888","NCT06739122","A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)","A Phase 3, Open-Label, Multicenter, Single-Arm Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Dulaglutide 3.0 mg and 4.5 mg in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* Have Type 2 diabetes treated with diet and exercise and metformin and\u002For basal insulin. Metformin and\u002For basal insulin dose must be stable for at least 8 weeks prior to screening.\n* Have a body weight ≥50 kilograms (kg) and Body Mass Index (BMI) of \\>85th percentile\n\nExclusion Criteria:\n\n* Have Type 1 diabetes\n* Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or dulaglutide within 8 weeks prior to screening\n* After the Type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome\n* Have had ≥1 episode of severe hypoglycemia and\u002For ≥1 episode of hypoglycemic unawareness within the last 6 months\n* Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)\n* Have prior chronic, recurrent, or idiopathic pancreatitis, or known gallbladder disease\n* Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 8 weeks prior to screening","10 Years","17 Years",{"count":395,"type":22},55,[67],"The main purpose of this study is to evaluate additional dosing options for dulaglutide in pediatric participants with Type 2 Diabetes. Participation in this study will last about 8 months.",[28],"2026-08-06",{"date":401,"type":48},"2026-08-07",{"date":403,"type":48},"2025-01-10",{"date":405,"type":22},"2027-12",{"name":131,"class":77},51,{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":23,"phases":417,"briefSummary":418,"conditions":419,"keywords":421,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":56},"100632184","cgm-after-discharge-from-hospital-100632184","NCT07510386","CGM After Discharge From Hospital","Continuous Glucose Monitoring for Post-discharge Diabetes Management","Inclusion Criteria:\n\n* Adult 18 years or older.\n* Inpatient treatment for type 2 or steroid induced diabetes during hospitalization, with plan for insulin use after discharge.\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Plan for discharge to rehabilitation\u002Fskilled nursing\u002Fhospice facility\n* Contra-indication to sensor placement\n* Pregnancy",{"count":416,"type":22},64,[25],"This is an investigator initiated prospective, randomized controlled trial which aims to compare two groups of patients with either type 2 or steroid-induced diabetes who are discharged with insulin. The intervention group will use the Libre 3 Plus continuous glucose monitoring (CGM) system at discharge, while the control group will use blinded CGM and fingerstick monitoring. Both the intervention and control groups will wear the sensor for 28 days post discharge and participate in telehealth diabetes management visits. The target enrollment for the study is 65 participants and participants are expected to be in the study for up to 35 days.",[28,420],"Steroid-induced Diabetes",[422,423],"discharge","CGM","2026-08-05",{"date":377,"type":48},{"date":427,"type":22},"2026-09-30",{"date":429,"type":22},"2026-11",{"name":431,"class":55},"Icahn School of Medicine at Mount Sinai",{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":87,"enrollmentInfo":439,"targetDuration":4,"studyType":23,"phases":440,"briefSummary":441,"conditions":442,"keywords":443,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":451},"100631577","phase-2-phase-2-trial-of-icovamenib-in-participants-with-type-2-diabetes-who-are-not-achieving-glycemic-targets-100631577","NCT07502495","Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets","A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets Despite Antihyperglycemic Medications","Key Inclusion Criteria:\n\n1. Males or females, age ≥18 years and ≤75 years\n2. Diagnosed with T2D\n3. Have been treated with lifestyle management with 1 to 3 antihyperglycemic medications: metformin, SGLT2i, alogliptin, or sitagliptin with a stable dose for at least 3 months prior to screening (if participants are taking metformin they must be on a minimum stable dose of ≥500 mg\u002Fday)\n4. Have HbA1c ≥7.5 and ≤10.5%\n5. Have a BMI ≤32 kg\u002Fm2\n6. Female participants of childbearing potential must have a negative pregnancy test, must be non-lactating, must be willing to have additional pregnancy tests during the study, and must agree to the sex and contraception requirements.\n7. Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests.\n\nKey Exclusion Criteria:\n\n1. Have type 1 diabetes mellitus or a secondary form of diabetes\n2. Have a history of diabetic ketoacidosis or hyperosmolar coma in the 6 months prior to screening\n3. Have positive GAD autoantibody result within 60 days prior to screening\n4. Have a history of severe hypoglycemia (defined by the occurrence of hypoglycemia symptoms requiring the assistance of another person for recovery) in the 6 months prior to screening or a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms as judged by the investigator\n5. Have personal or family history (first-degree relative) of MEN1\n6. Use of GLP-1 RA, dual GIP\u002FGLP-1 RA, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, \\[linagliptin, saxagliptin (these 2 are drugs within DPP-4i class)\\], bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin in the 3 months prior to screening\n7. Have fasting triglyceride ≥500 mg\u002FdL\n8. Have an eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m2 by the CKD-EPI Creatinine Equation at screening\n9. Have impaired liver function, defined as screening AST or ALT \\>1.2×ULN, and\u002For total bilirubin \\>ULN",{"count":132,"type":22},[119],"This is a Phase 2, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of icovamenib in participants with Type 2 Diabetes who are not achieving glycemic targets despite antihyperglycemic medications.",[28],[28],{"date":401,"type":48},{"date":446,"type":48},"2026-03-27",{"date":448,"type":22},"2027-09",{"name":450,"class":77},"Biomea Fusion Inc.",18,{"id":453,"slug":454,"hasResults":12,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":17,"sex":18,"minAge":459,"maxAge":369,"enrollmentInfo":460,"targetDuration":4,"studyType":204,"phases":4,"briefSummary":462,"conditions":463,"keywords":464,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":108},"100572195","youth-onset-type-2-diabetes-and-heart-disease-the-young-at-heart-prospective-cohort-study-100572195","NCT06730113","Youth-Onset Type 2 Diabetes and Heart Disease: The Young at Heart Prospective Cohort Study","Youth-onset Type 2 Diabetes and Heart Disease: The Young at Heart Prospective Cohort Study","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet the following criteria according to their group:\n\nFour categories of participants will be included in this study and the inclusion criteria for each group are given below:\n\n1. Participants with Y-T2DM\n\n1a.Age 12-25 years\n\n1b.Type 2 diabetes mellitus as defined by fasting blood glucose \\>= 126 mg\u002FdL OR postprandial blood sugar \\>= 200 mg\u002FdL OR Hemoglobin A1c \\>= 6.5% per American Diabetes Association Criteria and one element from the medical history consistent with ADA or AAP guidelines including: family history of diabetes and obesity, maternal or personal history of gestational diabetes, high-risk race and ethnicity, history of cardiovascular disease, hypertension, dyslipidemia, polycystic ovary syndrome, physical inactivity, other clinical conditions associated with insulin resistance (e.g. severe obesity, acanthosis nigricans, prediabetes), small or large for gestational age birth weight, history of breastfeeding, gestational history of illicit drugs including alcohol, smoking OR documentation of type 2 diabetes diagnosed at \\\u003C=25 years of age with verified medical history (as above).\n\n2\\. Youth with overweight\u002F obesity (Y-OW)\n\n2a. Age 12-25 years\n\n2b. For participants \\\u003C 18 years of age, BMI \\>= 85th percentile (overweight) and \\>= 95th percentile (obesity) for age and sex OR\n\n2c. For participants \\>= 18 years of age, BMI \\>=25\\\u003C30 kg\u002Fm\\^2 (overweight) or \\>=30 kg\u002Fm\\^2 (obesity)\n\n2d. Participants with obesity may have a diagnosis of prediabetes, defined as fasting blood glucose 100-125 mg\u002FdL OR postprandial blood sugar 140-199 mg\u002FdL OR HbA1c 5.7-6.4 percent (either during testing at NIH or as previously documented on outside medical record).\n\n3\\. Healthy control lean participants (Y-Lean)\n\n3a. Age 12-25 years\n\n3b. For participants \\\u003C 18 years of age, BMI \\\u003C= 85th percentile for age and sex OR\n\n3c. For participants \\>=18 years of age, BMI 18-24.99 kg\u002Fm\\^2.\n\n3d. HbA1c \\\u003C5.7 percent (either during testing at NIH or as previously documented on outside medical record).\n\n4\\. Biological parents of Y-T2DM, Y-OW and Y-Lean participants\n\n4a. Biological parent of enrolled Y-T2DM, Y-OW and Y-Lean by self-report.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria for their specific group will be excluded from participation in this study:\n\n1\\. Y-T2DM, Y-OW and Y-Lean Participants:\n\n1a. Type 1 diabetes or the presence of \\>2 diabetes auto-antibodies (e.g., GAD-65, IA-2 antigen, Zinc transporter 8 autoantibodies).\n\n1. b. Medical, psychiatric or cognitive disorders that will, in the opinion of the investigators, limit the subject s ability to comply with study procedures (specific obesity-related comorbidities are explicitly permitted, including hypertension, hyperlipidemia, obstructive sleep apnea and non-alcoholic steatohepatitis).\n\n1c. Serious medical illnesses or diseases thought to alter metabolism (including moderate to severe renal disease (\\\u003C 30 mL\u002Fmin\u002F1.73m\\^2), congenital heart disease, Cushing s syndrome, cancer, or other metabolic diseases associated with diabetes or excess weight).\n\n1d. For participants enrolled at the NIH, dietary allergies, intolerances or eating patterns that would preclude them from consuming metabolic meals.\n\n1e. Unwilling to comply with all study procedures or to adhere to Lifestyle Considerations throughout study duration.\n\n1f. Pregnancy at the time of the screening visit.\n\n1g. Clinically significant anemia OR Hematocrit below the lower limit of normal for age and sex cutoffs.\n\n1. h. For Y-OW Participants- Meet lab and medical history criteria for Y-T2DM as described in inclusion criterion 1b above.\n\n2\\. Y-Lean participants:\n\nIn addition to the above exclusion criteria, any Y-Lean participant who meets any of the following additional criteria will be excluded from the study:\n\n2a. Current use of prescription or non-prescription medication. Certain exceptions are permitted, including topical medications, vitamins, and hormonal contraceptives. Other medications may be permitted at the discretion of the investigators.\n\n2b. Recent (past 2 months) use of drugs or supplements that alter glucose or lipid metabolism (e.g., niacin, fish oil, red yeast rice)\n\n2c. History of diabetes or abnormal glucose tolerance\n\n2d.. Abnormal screening labs, including the following:\n\ni) ALT or AST \\>2 times the upper limit of normal\n\nii) Glycosuria\n\niii) Low eGFR (\\\u003C90 mL\u002Fmin\u002F1.73m\\^2)Any other abnormality that, in the opinion of the investigator, will increase risk to the subject from participation, or interfere with interpretation of study data\n\n2e. Meet lab and medical history criteria for Y-T2DM as described in inclusion criterion 1b above.\n\n3\\. Biological Parents\n\n-No Exclusion Criteria","12 Years",{"count":461,"type":22},930,"Background:\n\nType 2 diabetes is a disease that affects blood sugar levels. Complications can include heart and blood vessel (vascular) diseases. Rates of type 2 diabetes have tripled in children and young adults over the last 40 years. Vascular diseases are also increasing in young people.\n\nObjective:\n\nTo learn more about factors, including type 2 diabetes, that may cause vascular disease in young people.\n\nEligibility:\n\nPeople aged 12 to 25 years who (1) have type 2 diabetes; (2) are overweight but not diabetic; (3) or are lean and healthy. Biological parents are also needed.\n\nDesign:\n\nYoung participants will visit the NIH clinic once a year for up to 25 years. Each visit will take 4 days. Before each visit, participants will wear devices to track their sleep, activity, and blood sugar levels for 7 to 10 days.\n\nAt each visit, participants will have tests including:\n\nSamples: They will provide blood, urine, and stool samples.\n\nHeart: They will ride a stationary bike for 6 minutes with stickers applied to their chest.\n\nScans: They will lie on a bed that slides into a tube; the machine will take pictures of the inside of their body.\n\nEnergy: They will wear a hood over their head to measure the air they breathe.\n\nSocial stress: They will give a speech for 10 minutes to show their body s response to stress.\n\nGlucose: They will drink a sweet drink to see how their blood sugar changes.\n\nBiological parents will have 1 study visit. They will have blood tests. They will fill in questionnaires about their lifestyle and stress.\n\n...",[123,28],[465,124,123,466,467],"Cardiovascular Disease","Youth Onset Type 2 Diabetes","Lean","2026-08-04",{"date":424,"type":48},{"date":471,"type":48},"2025-03-12",{"date":473,"type":22},"2033-10-31",{"name":475,"class":476},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":23,"phases":486,"briefSummary":487,"conditions":488,"keywords":497,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":56},"100626901","families-implementing-good-health-traditions-for-life-100626901","NCT07441655","Families Implementing Good Health Traditions for Life","FIGHT for Life","Inclusion Criteria:\n\n1. Family 1.a.) Black Parent\u002FGuardian: age 18 years or older residing in the same household with child (i.e., biological or have legal guardianship for child) 1.b.) Child: age 8-15 years old\n2. Parent\u002FGuardian have HbA1c level 5.7-6.4% (prediabetes)\n3. Parent\u002FGuardian willing to commit to participation in a 20-month research study and have no plans to move from the area over the next 20-months\n4. Parent\u002Fchild are ambulatory and able to participate in physical activity\n\nExclusion Criteria:\n\n1. Individuals with severe psychological disorders that may prevent\u002Finterfere with study participation\n2. Physical impairments that may prevent participation in moderate intensity physical activity;\n3. Previous diagnosis of diabetes\n4. History of congestive heart failure, renal failure, or recent (\\\u003C12 months) cardiovascular events such as myocardial infarction or stroke;\n5. Person taking medications that may affect endpoint analyses\n6. Persons with co-morbid contraindications to physical activity or dietary changes.\n7. Currently pregnant or planning to become pregnant in the next year.",{"count":485,"type":22},70,[25],"This study will provide evidence for the utility of using a community-engaged research approach to implement a tailored, family-oriented adaptation of the Diabetes Prevention Program that will have positive effects on risk factors associated with type 2 diabetes morbidity and mortality among Black families in a Southwest Georgia community.",[489,490,28,491,492,493,494,495,496],"Diabetes","Chronic Disease","Healthy Lifestyle","Nutrition, Healthy","Sedentary Behavior","Family","Family Research","Family and Household",[498,499,500,501,502,503,504,505,506,507],"diabetes","rural","type 2 diabetes","nutrition","physical activity","diabetes prevention","family research","family and household","chronic disease","sedentary behavior","2026-08-03",{"date":424,"type":48},{"date":511,"type":48},"2026-02-01",{"date":513,"type":22},"2028-07-31",{"name":515,"class":55},"Morehouse School of Medicine",{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":18,"minAge":524,"maxAge":170,"enrollmentInfo":525,"targetDuration":4,"studyType":23,"phases":527,"briefSummary":528,"conditions":529,"keywords":537,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":547,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":56},"100605783","the-groceries-aimed-at-increasing-nutrition-study-100605783","NCT07167004","The GRoceries Aimed at Increasing Nutrition Study","Prompting a Switch From Refined Grains to Whole Grains in an Online Grocery Store Using Marketing Nudges and Financial Incentives","GRAINS","Inclusion Criteria:\n\n* Age 45 - 70 years.\n* Able to provide consent.\n* Resident of Philadelphia, Bucks, Delaware, Chester, or Montgomery Counties in Pennsylvania.\n* Consume \\\u003C5 servings of whole grains per day.\n* Use online grocery shopping at least once per month.\n* Have access to a credit or debit card to pay for groceries purchased.\n* Have reliable internet access.\n* Speak English.\n* Penn Medicine patient diagnosed with prediabetes or diabetes (identified using ICD-10 codes R73.03, E11).\n\nExclusion Criteria:\n\n* Does not meet all the inclusion criteria.\n* Not able to speak English.\n* Not able to provide consent.","45 Years",{"count":526,"type":22},216,[25],"Only 2% of Americans meet the recommended levels of whole grain consumption, despite its association with reduced risk of type 2 diabetes. This study aims to assess if consumers with prediabetes or type 2 diabetes can be encouraged to switch from buying refined grain products to whole grain products when shopping for groceries online. The study will use personalized marketing strategies, with or without discounts which adjust based on purchasing behavior, to promote whole grain consumption.",[28,530,531,532,533,534,535,154,536],"Type II Diabetes Mellitus","Type II Diabetes","Pre-diabetes","Pre-diabetic","Pre-diabetic State","Type 2 Diabetes Mellitus (T2DM)","Type 2 Diabetes (T2DM)",[506,498,538,539,500,540,541,542,543,544,545,546],"diabetes mellitus","type II diabetes","pre-diabetes","prediabetes","whole grains","behavioral economics","marketing nudges","financial incentives","food is medicine",{"date":399,"type":48},{"date":549,"type":48},"2025-10-14",{"date":551,"type":22},"2027-02-16",{"name":553,"class":55},"University of Pennsylvania",{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":4,"eligibilityCriteria":560,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":524,"enrollmentInfo":561,"targetDuration":4,"studyType":23,"phases":562,"briefSummary":563,"conditions":564,"keywords":573,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":56},"100529981","effect-of-sleep-extension-on-ceramides-in-people-with-overweight-and-obesity-100529981","NCT06180837","Effect of Sleep Extension on Ceramides in People With Overweight and Obesity","Biomarkers of Habitual Short Sleep and Related Cardiometabolic Risk","Inclusion Criteria:\n\n1. Age: 18-45 years old; equal numbers of men and women\n2. Body mass index (BMI): 27.5-34.9 kg\u002Fm2\n3. Sleep Habits: habitual self-reported average total sleep time (TST) \\\u003C6.5 hours per night for prior 6 months\n\nExclusion Criteria:\n\n1. Clinically diagnosed sleep disorder or major psychiatric illness\n2. Evidence of significant organ dysfunction or disease (e.g., heart disease, kidney disease)\n3. Clinically diagnosed diabetes or fasting plasma glucose ≥126 mg\u002FdL or HbA1c ≥6.5%\n4. Use of prescription drugs or substances known to influence sleep or glucose metabolism, or anticoagulant medications.\n5. Cancer that has been in remission less than 5 years\n6. Pregnant\u002Fnursing, experiencing menopause or post-menopausal\n7. Shift-work: current or history of within last year\n8. Weight change: \\>10% of body weight over prior six months\n9. Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program\n10. Currently smoking\n11. Alcohol intake\\>14 drinks per week or \\>3 drinks per day",{"count":485,"type":22},[25],"The overall goal is to determine how a sleep extension intervention (increasing time in bed) in individuals who maintain less than 6.5 hours sleep per night affects their plasma ceramides and insulin sensitivity. Participants will undergo a randomized controlled trial, with sleep extension (intervention) and healthy lifestyle (control) groups. The sleep extension is designed to increase participant's time in bed by 2 hours per night. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).",[565,566,567,568,569,28,570,571,572],"Lifestyle Factors","Overweight and Obesity","Insulin Sensitivity","Eating Habit","Sleep Hygiene","Sleep","Sleep Deprivation","Insufficient Sleep Syndrome",[574,575],"sleep","insulin sensitivity",{"date":424,"type":48},{"date":578,"type":48},"2024-02-12",{"date":580,"type":22},"2028-05",{"name":582,"class":55},"University of Utah",{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":589,"eligibilityCriteria":590,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":524,"enrollmentInfo":591,"targetDuration":4,"studyType":23,"phases":593,"briefSummary":594,"conditions":595,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":598,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":603,"locationsCount":56},"100511760","circadian-intervention-to-improve-cardiometabolic-health-100511760","NCT05943626","Circadian Intervention to Improve Cardiometabolic Health","Timing of Circadian Synchronizers: The TOCS Study","TOCS","Inclusion Criteria:\n\n1. Age: 18-45 years old; equal numbers of men and women\n2. Body mass index (BMI): 25.0-34.9 kg\u002Fm2,\n3. Sleep Habits: habitual self-reported average total sleep time (TST) \\\u003C6.5 hours per night for prior 6 months\n\nExclusion Criteria:\n\n1. Clinically diagnosed sleep disorder or major psychiatric illness\n2. Evidence of significant organ dysfunction or disease (e.g., diagnosed diabetes, cardiovascular disease, or kidney disease)\n3. Use of prescription drugs or substances known to influence sleep or glucose metabolism\n4. Shift-work: current or history of within last year\n5. Weight change: \\>10% of body weight over prior six months\n6. Experiencing menopause or post-menopausal\n7. Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program\n8. Currently pregnant or planning to become pregnant, or currently lactating.\n9. Currently smoking\n10. Alcohol intake \\>3 drinks per day or \\>14 drinks per week",{"count":592,"type":22},20,[25],"The overall goal is to examine the efficacy of a circadian intervention in people with overweight and obesity and habitual short sleep duration (HSSD). Participants will undergo a randomized controlled trial, with circadian intervention and control (healthy lifestyle) groups. The circadian intervention is designed to reduce nighttime light exposure and after-dinner snack food intake. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).",[596,28,570,597,565,566,567,568,569],"Cardiometabolic Syndrome","Time Restricted Feeding",{"date":424,"type":48},{"date":600,"type":48},"2023-06-13",{"date":602,"type":22},"2027-06",{"name":582,"class":55},{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":23,"phases":612,"briefSummary":613,"conditions":614,"keywords":617,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":623,"leadSponsor":624,"locationsCount":108},"100607355","outcomes-of-physiologic-insulin-resensitization-pir-in-patients-with-chronic-kidney-disease-and-type-2-diabetes-mellitus-100607355","NCT07187479","Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus","Randomized, Open Label Study to Examine the Outcomes of Physiologic Insulin Resensitization in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* Is age 18 or older (male or female)\n* Have a documented diagnosis of CKD stage 3b, 4, or 5 and T2DM of 6 months or greater prior to screening. Patients may have treatment regimens associated with T2DM that include diabetic oral and\u002For injectable medications including insulin and\u002For GLP-1 receptor agonists.\n* In the opinion of the Investigator, has been on an appropriate, stable regimen for management of any complications present for the past six (6) months.\n* In the opinion of the Investigator, is able to do all of the following:\n\n  * Provide valid informed consent.\n  * Understand and comply with study procedures as presented in the consent process.\n  * Has the capacity or support to attend all required visits.\n* If female, the subject must meet either of the following sets of conditions:\n\n  o Is of non-childbearing potential, defined as meeting either of the following criteria:\n* Age ≥50 years and post-menopausal for at least one (1) year\n* Surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\n* Is of childbearing potential and meets both of the following criteria:\n\n  * Has a negative serum pregnancy test (beta-human chorionic gonadotropin) at screening.\n  * Agrees to practice an acceptable method of birth control (contraception) from screening until at least 30 days after last study treatment\n\nExclusion Criteria:\n\n* Has in the past two (2) years received treatment for a malignancy.\n* Current pregnancy or intends to become pregnant during the study\n* Has in the past one (1) year used non-prescription opioids or psychoactive drugs.\n* Has in the past six (6) months had a hypoglycemic event requiring urgent care and\u002For administration of glucagon, osteocalcin, or parenteral glucose, unless approved for enrollment by the Medical Monitor.\n* Has within the past one (1) month participated in a clinical study involving either of the following:\n\n  * An investigational drug or procedure for any clinical indication\n  * An investigation method for glucose control using approved agents\n* Is nursing or is planning to nurse during the study.\n* Has at screening a positive test for HIV (4th gen. screen), HBsAg, or HCV viral load.\n* Has at screening, one or more of the following abnormal lab results:\n\n  * Hb \\\u003C8 g\u002FdL\n  * WBC \\\u003C2,000\u002FµL\n  * Platelets \\\u003C50,000\u002FµL\n  * ALT, AST, or Alkaline Phosphatase \\>5x ULN\n  * ALT or AST \\>2.5x ULN, and Total Bilirubin \\>2x ULN\n  * Serum albumin \\\u003C3 g\u002FdL\n* Has - in the opinion of the Investigator - psychiatric, behavioral, cognitive and\u002For clinical dysfunction (whether or not related to known medical illness or drug \u002F alcohol use) that would affect the subject's safety and\u002For compliance.\n* Is on active dialysis at time of screening",{"count":78,"type":22},[25],"The purpose of this research is to evaluate outcomes of physiologic insulin re-sensitization (PIR) in patients with Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM).",[615,616,28],"Chronic Kidney Disease (Stages 4 and 5)","Kidney Disease",[618,500,498,619],"chronic kidney disease","kidney disease","2026-08-01",{"date":468,"type":48},{"date":549,"type":48},{"date":288,"type":22},{"name":625,"class":77},"Well Cell Global",{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":4,"eligibilityCriteria":632,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":633,"targetDuration":4,"studyType":23,"phases":635,"briefSummary":636,"conditions":637,"keywords":638,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":649,"startDateStruct":650,"completionDateStruct":651,"leadSponsor":652,"locationsCount":56},"100580375","using-continuous-glucose-monitoring-to-quantify-the-effects-of-nourishs-culturally-modified-meals-on-asian-americans-with-type-2-diabetes-100580375","NCT06836479","Using Continuous Glucose Monitoring to Quantify the Effects of NOURISH's Culturally Modified Meals on Asian Americans With Type 2 Diabetes","Validation of NOURISH Project's Culturally Tailored Meals on Postprandial Glycemic Response Using Continuous Glucose Monitoring: A Quantitative and Qualitative Study","Inclusion Criteria:\n\n* Self-identification as Asian Indian or Filipino\n* Diagnosed with T2DM\n* Pick up and consume personally tailored cultural food and meal options for 1 week\n* Willing to wear a CGM for 30 days\n\nExclusion Criteria:\n\n* Currently taking insulin\n* Known severe allergic reactions and\u002For food intolerances that would interfere with the ability to eat\n* Those who, in the opinion of the investigators, cannot reliably complete the study protocol.",{"count":634,"type":22},30,[25],"The investigators are hoping to determine whether tailoring the diet of someone with type 2 diabetes to their ethnic group while following American Diabetes Association guidelines can make a significant difference in their blood sugar controls. Participants will be required to wear a Continuous Glucose Monitor (CGM) for 1-month so that the investigators can compare blood sugar levels when participants are eating their routine diet vs. the culturally tailored diabetes diet.",[535,28],[28,639,640,641,642,643,644,645,646,647,648],"Asian American","Asian Indian","Filipino","Medically Tailored Meals","Culture","Culturally Tailored Meals","Continuous Glucose Monitoring","Nutritional Interventions","Dietary Adherence","Diabetes Management",{"date":468,"type":48},{"date":211,"type":22},{"date":429,"type":22},{"name":653,"class":55},"Stanford University",{"id":655,"slug":656,"hasResults":12,"nctId":657,"briefTitle":658,"officialTitle":659,"acronym":660,"eligibilityCriteria":661,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":170,"enrollmentInfo":662,"targetDuration":4,"studyType":23,"phases":664,"briefSummary":665,"conditions":666,"keywords":669,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":672,"lastUpdatePostDateStruct":673,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":678,"locationsCount":56},"100650682","effectiveness-of-a-low-calorie-diet-combined-with-intensive-lifestyle-intervention-using-integrated-personalized-diabetes-management-for-achieving-diabetes-remission-in-patients-with-type-2-diabetes-mellitus-100650682","NCT07748949","Effectiveness of a Low-Calorie Diet Combined With Intensive Lifestyle Intervention Using Integrated Personalized Diabetes Management for Achieving Diabetes Remission in Patients With Type 2 Diabetes Mellitus","Effectiveness of a Low-Calorie Diet Combined With Intensive Lifestyle Intervention Using Integrated Personalized Diabetes Management for Achieving Diabetes Remission in Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Trial","REMIT-DM","Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes mellitus with HbA1c level of 6.0 to 9.0%. Participants with HbA1c of 6.0 to 6.4% were required to be receiving oral glucose lowering medication.\n* Diagnosed with type 2 diabetes mellitus for less than 6 years.\n* Body mass index of 23 kg\u002Fm2 or greater.\n\nExclusion Criteria:\n\n* Receiving more than two oral glucose-lowering medications.\n* Receiving insulin therapy.\n* Use of a glucagon-like peptide-1 receptor agonist (GLP-1 RA) within 3 months before study enrollment.\n* Use of medications known to affect HbA1c within 3 months before study enrollment, including corticosteroids, vitamin C (excluding vitamin C obtained from natural dietary sources or fruits), vitamin E, trimethoprim-sulfamethoxazole, or hydroxyurea.\n* History of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.\n* Unstable psychiatric disorders within the previous 2 years, including major depressive disorder, bipolar disorder, or schizophrenia.\n* Pregnant or breastfeeding women, or women planning to become pregnant within 12 months.\n* Presence of any of the following medical conditions based on medical history and clinical records, including chronic kidney disease with an estimated glomerular filtration rate less than 45 mL\u002Fmin\u002F1.73 m2, liver cirrhosis or hepatitis with alanine aminotransferase or aspartate aminotransferase more than 3 times the upper limit of normal, chronic alcohol abuse, hypothyroidism with thyroid-stimulating hormone more than 10 uIU\u002FmL, HIV infection, anemia (hemoglobin less than 10 g\u002FdL), iron deficiency, vitamin B12 deficiency, folate deficiency, thalassemia, glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia, or hemoglobin more than 16 g\u002FdL, heart failure or ischemic heart disease within the previous 6 months.\n* History of blood donation or blood transfusion within the previous 3 months.\n* Uncontrolled diabetic retinopathy or other uncontrolled retinal disease, including maculopathy, based on medical records.\n* Signs, symptoms, or a history of malignancy within 5 years before screening, except for basal cell carcinoma, squamous cell carcinoma of the skin, or other carcinoma in situ.\n* Major surgery within 90 days before enrollment or planned major surgery within 6 months after enrollment.\n* No access to a smartphone capable of supporting the study application and internet-based data transmission.\n* Unable to maintain communication with the study investigators according to the study protocol.",{"count":663,"type":22},54,[25],"The goal of this clinical trial is to determine whether a low-calorie diet combined with intensive lifestyle intervention using Integrated Personalized Diabetes Management (iPDM) is more effective than standard care in achieving diabetes remission in adults with overweight and type 2 diabetes mellitus. The study will also evaluate the effects of the intervention on metabolic and clinical outcomes associated with diabetes remission.\n\nThe main questions it aims to answer are:\n\n* Does a low-calorie diet combined with intensive lifestyle intervention using iPDM increase the proportion of participants who achieve diabetes remission compared with standard care?\n* Does the intervention improve metabolic and patient-centered outcomes, including glycemic control, body weight, body composition, Time in Range (TIR) measured by continuous glucose monitoring (CGM), quality of life, and cost-effectiveness?\n\nResearchers will compare participants receiving a low-calorie diet combined with intensive lifestyle intervention using iPDM with participants receiving standard diabetes care to determine whether the intervention is more effective in achieving diabetes remission and improving metabolic health.\n\nParticipants will:\n\n* Be randomly assigned to either the intervention group or the standard care group.\n* Attend study visits for assessments of diabetes-related clinical and metabolic outcomes throughout the 6-month study.\n* If assigned to the intervention group, consume two low-calorie meal replacements per day and follow an individualized meal plan providing no more than 1,200 kcal per day during the first 3 months (intensive phase), together with a personalized exercise program, continuous glucose monitoring (CGM), and lifestyle counseling delivered via telemedicine every 2 weeks. During the following 3 months (maintenance phase), continue lifestyle modification with reinforcement sessions delivered via telemedicine every 4 weeks while following a meal plan providing no more than 1,500 kcal per day.",[28,178,667,668],"Remission","Lifestyle Intervention",[670,28,123,671],"Diabetes remission","Lifestyle intervention","2026-07-31",{"date":399,"type":48},{"date":675,"type":48},"2026-06-17",{"date":677,"type":22},"2027-07-31",{"name":679,"class":55},"Chulalongkorn University"]