Effect of Low-Calorie Diet and Lifestyle Intervention on Reversal of T2DM

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.

NCT Number	NCT05925946
Lead Sponsor	Diabetes Foundation, India Collaborators: Ministry of Science and Technology, India
Conditions	Diabetes Mellitus, PreDiabetes, Diet Habit
Enrollment	60 participants
Start Date	2023-10-01
Primary Completion	2026-09-30 (estimated)
Study Completion	2026-10-31 (estimated)
Updated on ClinicalTrials.gov	2023-06-29