[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Diabetes Foundation, India\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":134},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,39,64,86,109],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100608757","impact-of-partially-replacing-wheat-with-millets-or-bengal-gram-flour-in-rotis-on-glycemia-and-prediabetes-reversal-100608757",false,"NCT07205705","Impact of Partially Replacing Wheat With Millets or Bengal Gram Flour in Rotis on Glycemia and Prediabetes Reversal","Inclusion Criteria:\n\n1. Age 18 to 60 years\n2. Prediabetes as diagnosed on oral glucose tolerance test (OGTT): Fasting blood glucose ≥100mg\u002Fdl and \\\u003C126 mg\u002Fdl and\u002For 2-h plasma glucose ≥140mg\u002Fdl and \\\u003C200mg\u002Fdl (after ingestion of 75 gram anhydrous oral glucose).\n\nExclusion Criteria:\n\n1. Acute infections and advanced end-organ damage\n2. History of hepatitis or pancreatitis, abnormal liver and renal functions\n3. Recent (\\\u003C3 months) changes in weight (≥5%) and\u002For weight-changing medications\n4. Any known allergy to wheat or any other grain\n5. Subjects with uncontrolled hypothyroidism or hypertension\n6. On any drug causing weight gain or weight loss","ALL","18 Years","60 Years",{"count":19,"type":20},140,"ESTIMATED","INTERVENTIONAL",[23],"NA","There is limited research on the impact of millets on glycemia, and it remains unclear whether partially replacing wheat in rotis with low glycemic index millets or Bengal gram flour offers greater glycemic benefits compared to whole wheat. This approach has the potential to reduce postprandial and overall glycemia, supporting the reversal of prediabetes through dietary modification alone. This study introduces a novel formulation of rotis using 50:50 blends of wheat with either barnyard millet, barley, or Bengal gram flour, aiming to improve glycemic control without compromising taste. Glycemic response is assessed through a combination of meal tolerance tests, continuous glucose monitoring, and a three-month dietary intervention, providing both immediate and long-term data. Additionally, the study includes a comprehensive metabolic evaluation by measuring serum insulin, inflammatory markers, and free fatty acids key indicators in the progression of prediabetes. Conducted as a randomized controlled trial with 80 participants across four arms (20 per arm), the study comprises three phases: Phase I evaluates immediate glycemic response through a meal tolerance test; Phase II uses continuous glucose monitoring over three days to monitor fluctuations in glucose levels; and Phase III, with 140 participants, assesses the long-term impact of the dietary intervention over three months. The primary objectives are to determine the effect of the interventions on glycemic response and HbA1c, with an expected outcome of a 10% reduction in the area under the curve for overall and postprandial glucose in Phases I and II, and a 10% reduction in HbA1c in Phase III.",[26],"Pre Diabetes","NOT_YET_RECRUITING","2025-09-25",{"date":30,"type":31},"2025-10-03","ACTUAL",{"date":33,"type":20},"2025-11-15",{"date":35,"type":20},"2027-11-20",{"name":37,"class":38},"Diabetes Foundation, India","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":45,"sex":15,"minAge":46,"maxAge":17,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100551029","phase-3-to-evaluate-the-impact-of-consumption-of-bioactive-compounds-extracted-from-hemp-hull-and-black-pepper-on-fasting-blood-glucose-levels-in-people-with-pre-diabetes-a-randomized-placebo-controlled-parallel-arm-trial-100551029","NCT06454773","To Evaluate the Impact of Consumption of Bioactive Compounds Extracted From Hemp Hull and Black Pepper on Fasting Blood Glucose Levels in People With Pre-diabetes: A Randomized Placebo-Controlled Parallel Arm Trial","Inclusion Criteria:\n\n* Prediabetic individuals of BMI range 25-30 kg\u002Fm2 and waist circumference ≥80cm for women and ≥90cm for men with Fasting Blood Glucose between 100-125 mg\u002FdL.\n\nExclusion Criteria:\n\n* Prediabetic individuals of BMI range 25-30 kg\u002Fm2 and waist circumference ≥80cm for women and ≥90cm for men with Fasting Blood Glucose between 100-125 mg\u002FdL.\n\nExclusion criteria\n\n1. Weight loss or gain ≥4.5 kg within 90 days of visit 1.\n2. Use of weight loss medications within 90 days of visit 1\n3. History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight\u002Ffat reducing purposes.\n4. Use of dietary supplements or related products that, in the judgment of the Investigator, are likely to markedly affect weight loss or appetite within 30 days of visit 1.\n5. History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator.\n6. History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.\n7. Current medical diagnosis of type 1 or type 2 diabetes mellitus.\n8. HbA1c ≥48 mmol\u002Fmol (6.5%) as measured at visit 1.\n9. History of a chronic gastrointestinal disorder, such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).\n10. Signs or symptoms of an active infection of clinical relevance within 5 days of visit 1. The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to visit 1.\n11. Is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source document.\n12. Any condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.\n13. Excessive alcohol consumption (\\> 2 Drinks, 60 ml of Whisky Per Day).",true,"25 Years",{"count":48,"type":20},130,[50],"PHASE3","This is randomized controlled parallel arm study on free living Asian Indians. Eligible subjects will undergo one-week run-in period and subjects will be asked to maintain their usual diet and exercise regime. At the end of the run-in period, subjects fulfilling the inclusion\u002Fexclusion criteria at this stage will be randomized either to the intervention arm or control arm using computerized random number tables.\n\nThe measured parameters will include, 24-h diet recall, food frequency questionnaire, anthropometry including circumferences, height and weight, and blood parameters including blood glucose (fasting), serum insulin (fasting), HbA1c and lipid profile.",[53],"Intervention","RECRUITING","2024-06-06",{"date":57,"type":31},"2024-06-12",{"date":59,"type":31},"2024-06-01",{"date":61,"type":20},"2024-12-31",{"name":37,"class":38},1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":45,"sex":15,"minAge":16,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":4},"100510399","high-protein-diet-on-transcriptomic-metabolomics-hepatic-and-pancreatic-fat-anatomy-and-physiology-in-asian-indians-with-pre-diabetes-100510399","NCT05925933","High Protein Diet on Transcriptomic, Metabolomics, Hepatic and Pancreatic Fat Anatomy and Physiology in Asian Indians With Pre-diabetes","Effect of High Protein Diet on Transcriptomic Regulations, Plasma Metabolomics, Hepatic and Pancreatic Fat Anatomy and Physiology in Asian Indians With Pre-diabetes","Exclusion Criteria:\n\n* Acute infections and advanced end-organ damage.\n* History of hepatitis or pancreatitis, abnormal liver and renal function tests.\n* Recent (\\\u003C3 months) changes in weight (≥5%) and\u002For weight changing medications.\n* Subjects with metallic implants, pacemaker leads, radioactive seeds or surgical staples in the body.\n\nInclusion Criteria\n\nCases:\n\n* Age 18 to 50 years. Subjects with pre-diabetes on oral glucose tolerance test (OGTT)\n* Fasting blood glucose≥100mg\u002Fdl and \\\u003C126 mg\u002Fdl or 2-h plasma glucose ≥140mg\u002Fdl and \\\u003C200mg\u002Fdl (after ingestion of 75 grams of anhydrous oral glucose) or both.\n\nControls:\n\n* Age 18 to 50 years. Normoglycemia by OGTT\n* Fasting blood glucose \\\u003C100mg\u002Fdl and 2-h plasma glucose \\\u003C140mg\u002Fdl (after ingestion of 75 gram of anhydrous oral glucose).","50 Years",{"count":73,"type":20},60,[23],"Diabetes\u002F prediabetes is a substantial problem in India not only because it itself can be associated with morbidities such as coronary artery disease but also because it is a point of importance for the prevention of other diseases. It is not clear if a high protein calorie diet in the Indian population associated with a heightened tendency for prediabetes, metabolic syndrome, atherosclerosis and dysmetabolic state etc. could, besides lifestyle factors, be related to diet, or interaction between the two. The analysis of whole blood transcriptomes and plasma metabolomics profiles may be a potentially useful tool for the assessment of metabolic health status. The proposed study is the first to perform a detailed gene expression profiling with the use of next-generation sequencing technology to assess the differences in molecular mechanisms in the peripheral blood of subjects with prediabetes.",[77],"Pre-diabetes","2023-06-22",{"date":80,"type":31},"2023-06-29",{"date":82,"type":20},"2023-10-01",{"date":84,"type":20},"2026-10-31",{"name":37,"class":38},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":45,"sex":15,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":98,"conditions":99,"keywords":103,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":107,"leadSponsor":108,"locationsCount":4},"100510400","effect-of-low-calorie-diet-and-lifestyle-intervention-on-reversal-of-t2dm-100510400","NCT05925946","Effect of Low-Calorie Diet and Lifestyle Intervention on Reversal of T2DM","Effect of Low-Calorie Diet and Lifestyle Intervention on Reversal of Type 2 Diabetes Mellitus, Hepatic and Pancreatic Fat: A Two-year Randomized Control Trial in New Delhi, India","CURE-DM","Inclusion Criteria:\n\n* Diagnosed with T2DM within the previous 3 years\n* Age 20-65 years\n* BMI \\>25-45kg\u002Fm2\n* HbA1c\\> 6.5% at baseline (on current treatment, if any)\n\nExclusion criteria:\n\n* Recent or screening HbA1c of 9% or higher\n* Weight loss of \\>5 kg within the previous 6 months\n* Significant cardiopulmonary\n* Hepatic, or another endocrine disease\n* Current participation in any other research drug study in the previous three months\n* Past history of bariatric surgery Malignancy other than minor skin lesions and Possibility of pregnancy","20 Years","65 Years",{"count":73,"type":20},[23],"An increase in body fat, even when within the normal BMI range is one of the essential drivers of T2DM in Asian Indians. In this context, the relationship between excess hepatic fat and pancreatic fat appears to be necessary. A low-calorie (high protein and low carb) vegetarian diet with appropriate exercise, in a protocol similar to the DiRECT study, may lead to weight loss, reversal of diabetes, and decrease in ectopic fat.",[100,101,102],"Diabetes Mellitus","PreDiabetes","Diet Habit",[104],"Type 2 Diabetes, Low calorie diet, Asian Indians, hepatic fat, pancreatic fat",{"date":80,"type":31},{"date":82,"type":20},{"date":84,"type":20},{"name":37,"class":38},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":45,"sex":15,"minAge":94,"maxAge":17,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":4},"100476004","vitamin-d-supplementation-on-surrogate-markers-of-atherosclerosis-100476004","NCT05478291","Vitamin D Supplementation on Surrogate Markers of Atherosclerosis","Effect of Vitamin D Supplementation on Surrogate Markers of Atherosclerosis in North Indian Individuals With Pre-diabetes and Low Vitamin D Levels: a Randomised Controlled Trial.","Inclusion Criteria:\n\n* Pre-diabetes: fasting blood glucose ≥100mg\u002Fdl and \\\u003C125.99mg\u002Fdl, 2-h plasma glucose ≥140mg\u002Fdl and \\\u003C200mg\u002Fdl (after ingestion of 75 g anhydrous oral glucose).\n* Baseline level of 25 hydroxy vitamin D \\\u003C30ng\u002Fdl and aged 20-60 years.\n\nExclusion Criteria:\n\n* Received Vitamin D and\u002For calcium supplementation in the previous six months, on any medication within the last one month which could potentially influence insulin secretion, insulin sensitivity, vitamin D or calcium metabolism (eg metformin, thiazolidione, steroids etc) and on any medication that activate steroid and xenobiotic receptor and drugs used in transplantation (e.g. steriods, calcitonin etc.)\n* Severe end-organ damage, any malignancy, nephrotic syndrome, malabsorption etc,\n* Known case of HIV infection, hyperparathyroidism, granulomatous disorders (e.g. sarcoidosis)",{"count":117,"type":20},120,[23],"For this study, our sample population is individuals with prediabetes, who are at an increased risk for atherosclerosis. In this proposed randomized placebo-controlled prospective trial, we would be enrolling 120 subjects with prediabetes having vitamin D deficiency. These subjects will be randomized into two groups; lifestyle modification counselling along with intervention with either vitamin D supplementation or placebo. Clinical and dietary profiles including sunlight exposure, anthropometry, glycemic and lipid profiles, fasting insulin, adiponectin, body composition (DEXA), skinfolds (4 sites), surrogate markers of atherosclerosis\u002Finflammation (TNF-alpha, hs-CRP, Matrix Metalloproteinase-9, flow-mediated dilatation of brachial artery, pulse wave velocity, and carotid intima-mediated thickness) will be measured at week 0 and week.",[121],"Atherosclerosis",[123,124,125],"Vitamin D","Prediabetes","Asian Indians","2023-06-13",{"date":128,"type":31},"2023-06-15",{"date":130,"type":20},"2023-09-01",{"date":132,"type":20},"2026-08-30",{"name":37,"class":38},""]