Effect of Low-Calorie Diet and Lifestyle Intervention on Reversal of T2DM (CURE-DM)
Diabetes Mellitus, PreDiabetes, Diet Habit
About this trial
This is an interventional prevention trial for Diabetes Mellitus focused on measuring Type 2 Diabetes, Low calorie diet, Asian Indians, hepatic fat, pancreatic fat
Eligibility Criteria
Inclusion Criteria: Diagnosed with T2DM within the previous 3 years Age 20-65 years BMI >25-45kg/m2 HbA1c> 6.5% at baseline (on current treatment, if any) Exclusion criteria: Recent or screening HbA1c of 9% or higher Weight loss of >5 kg within the previous 6 months Significant cardiopulmonary Hepatic, or another endocrine disease Current participation in any other research drug study in the previous three months Past history of bariatric surgery Malignancy other than minor skin lesions and Possibility of pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention Group
Control Group
Phase1 (Partial diet replacement) (850 Kcal/day) (12-20 weeks)): Phase 2 (Gradual increase in calories) (20-28 weeks) (1100 Kcal/day): Phase 3 (Weight loss maintenance) (29-104 weeks) (up to 1200Kcal/day) :
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/day 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.