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Effect of Low-Calorie Diet and Lifestyle Intervention on Reversal of T2DM
Sponsor: Diabetes Foundation, India
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
20 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2023-10-01
Completion Date
2026-10-31
Last Updated
2023-06-29
Healthy Volunteers
Yes
Conditions
Interventions
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. 2. These subjects will be randomized into two groups by computer-generated randomization list using variable block size. 3. 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.