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

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus; PreDiabetes; Diet Habit
• Interventions: Dietary Supplement: CURE-DM

• Registration Number: NCT05925946
• Lead Sponsor: Diabetes Foundation, India

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-06-22
• Last Update Submitted: 2023-06-22
• Study First Posted: 2023-06-29
• Last Update Posted: 2023-06-29
• Study Start: 2023-10-01
• Primary Completion: 2026-09-30
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	CURE-DM	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) :

Primary Outcome Measures

Name	Time	Method
Reversal of diabetes	24 Months	This randomized controlled prospective trial will be of 2 years duration with T2D. These subjects will be randomized into two groups, Group A (intervention group) will receive a professionally supported low-calorie diet along with appropriate exercise counselling; Group B (Control group) will be receiving encouragement to follow standard diet and exercise advice.

Secondary Outcome Measures

Name	Time	Method
Hepatic and Pancreatic Fat	24 Months	Liver and pancreatic fat fraction (proton-density fat fraction-magnetic resonance imaging (PDFF-MRI) and thigh skeletal muscle area (by MRI).
Anthropometric assessment	24 Months	Weight, BMI, circumferences (waist, hip, mid-thigh, mid-arm and neck), skinfold thickness (biceps, triceps, sub scapular, supra-iliac, thigh, lateral thoracic and calf)
Muscle strength	24 Months	Handgrip muscle strength by Jamar Dynamometer
Insulin Resistance	24 Months	Surrogate markers of insulin sensitivity
Body fat	24 Months	Body fat will be done by Whole body dual-energy X-ray absorptiometry (DEXA scan