Effect of Low-Calorie Diet and Lifestyle Intervention on Reversal of T2DM (CURE-DM)

Diabetes Foundation, India

Status: Not yet enrolling

Conditions: Diet Habit; Diabetes Mellitus; PreDiabetes

Treatments: Dietary Supplement: CURE-DM

Study type: Interventional

Funder types: Other

Identifiers

NCT05925946

2022-1312

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Intervention Group

Experimental group

Description:

1. Phase1 (Partial diet replacement) (850 Kcal/day) (12-20 weeks)): 2. Phase 2 (Gradual increase in calories) (20-28 weeks) (1100 Kcal/day): 3. Phase 3 (Weight loss maintenance) (29-104 weeks) (up to 1200Kcal/day) :

Treatment:

Dietary Supplement: CURE-DM

Control Group

No Intervention group

Description:

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.