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

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.

Diabetes is one of the biggest global public health problems. India has 100 million people living with diabetes as per the 2023 data. Reversal of T2DM, the holy grail of diabetes management, was not deemed possible until recently. Primary care-led weight management for remission of type 2 diabetes (DiRECT) trial has been conducted in obese patients with T2DM patients for a period of 2 years in the UK. Research on the effect of dietary intervention would be necessary for Asian Indians since liver fat deposition is more severe than in white Caucasians. Although some nutritionists and physicians are replicating methods of DiRECT study in their patients, it is not clear if similar diets will work effectively in community-dwelling Asian Indians.

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