[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510400":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":18,"responsibleParty":34,"collaborators":36,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":22,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":18,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":64,"whyStopped":18,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":18},{"fullName":5,"class":6},"Diabetes Foundation, India","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","1. Phase1 (Partial diet replacement) (850 Kcal\u002Fday) (12-20 weeks)):\n2. Phase 2 (Gradual increase in calories) (20-28 weeks) (1100 Kcal\u002Fday):\n3. Phase 3 (Weight loss maintenance) (29-104 weeks) (up to 1200Kcal\u002Fday) :",[13],"Dietary Supplement: CURE-DM",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Subjects will be given routine care for diabetes and obesity management with no change in medication. The meal plan for the control group will consist of 1400 Kcal\u002Fday achieved through small frequently distributed meals constituting around 15% of protein, 60% of carbohydrates and 25% of fat; with a menu resembling standard Indian dietary patterns and meal combinations.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DIETARY_SUPPLEMENT","CURE-DM","1. This randomized controlled prospective trial will be of 2 years duration where 150 patients with T2DM from urban areas of Delhi will be screened.\n2. These subjects will be randomized into two groups by computer-generated randomization list using variable block size.\n3. Group A (n, 60, test group)will be received a low-calorie diet along with appropriate exercise counseling; and group B (n, 60, Control group) will be received balanced diet along with exercise advice.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Anoop Misra, MD","CONTACT","01141759672","anoopmisra@gmail.com",{"name":32,"role":28,"phone":29,"phoneExt":18,"email":33},"Surya Prakash, PhD+Post Doc","suryabhat@gmail.com",{"type":35,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[37],{"name":38,"class":39},"Ministry of Science and Technology, India","OTHER_GOV","100510400","effect-of-low-calorie-diet-and-lifestyle-intervention-on-reversal-of-t2dm-100510400",false,"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","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",true,"ALL","20 Years","65 Years",{"count":52,"type":53},60,"ESTIMATED","INTERVENTIONAL",[56],"NA","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.",[59,60,61],"Diabetes Mellitus","PreDiabetes","Diet Habit",[63],"Type 2 Diabetes, Low calorie diet, Asian Indians, hepatic fat, pancreatic fat","NOT_YET_RECRUITING","2023-06-22",{"date":67,"type":68},"2023-06-29","ACTUAL",{"date":70,"type":53},"2023-10-01",{"date":72,"type":53},"2026-10-31",{"name":5,"class":6}]