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

N/ANot Yet RecruitingNCT05925946

Diabetes Foundation, India60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus PreDiabetes Diet Habit

Interventions

CURE-DMDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Reversal of diabetes

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.

Time frame: 24 Months

Secondary Outcomes

Muscle strength

Handgrip muscle strength by Jamar Dynamometer

Time frame: 24 Months

Anthropometric assessment

Weight, BMI, circumferences (waist, hip, mid-thigh, mid-arm and neck), skinfold thickness (biceps, triceps, sub scapular, supra-iliac, thigh, lateral thoracic and calf)

Time frame: 24 Months

Hepatic and Pancreatic Fat

Liver and pancreatic fat fraction (proton-density fat fraction-magnetic resonance imaging (PDFF-MRI) and thigh skeletal muscle area (by MRI).

Time frame: 24 Months

Body fat

Body fat will be done by Whole body dual-energy X-ray absorptiometry (DEXA scan

Time frame: 24 Months

Insulin Resistance

Surrogate markers of insulin sensitivity

Time frame: 24 Months