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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus; PreDiabetes; Diet Habit
• Intervention / Treatment: Dietary supplement: CURE-DM

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anoop Misra, MD; Phone Number: 01141759672; Email: anoopmisra@gmail.com
• Study Contact Backup: Name: Surya Prakash, PhD+Post Doc; Phone Number: 01141759672; Email: suryabhat@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Phase1 (Partial diet replacement) (850 Kcal/day) (12-20 weeks)):; Phase 2 (Gradual increase in calories) (20-28 weeks) (1100 Kcal/day):; Phase 3 (Weight loss maintenance) (29-104 weeks) (up to 1200Kcal/day) :	Dietary supplement: CURE-DM; This randomized controlled prospective trial will be of 2 years duration where 150 patients with T2DM from urban areas of Delhi will be screened.; These subjects will be randomized into two groups by computer-generated randomization list using variable block size.; 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.
No Intervention: Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength	Handgrip muscle strength by Jamar Dynamometer	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)	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).	24 Months
Body fat	Body fat will be done by Whole body dual-energy X-ray absorptiometry (DEXA scan	24 Months
Insulin Resistance	Surrogate markers of insulin sensitivity	24 Months

Collaborators and Investigators

• Sponsor: Diabetes Foundation, India
• Collaborators: Ministry of Science and Technology, India

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Type 2 Diabetes, Low calorie diet, Asian Indians, hepatic fat, pancreatic fat
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 2022-1312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This randomized controlled prospective trial will be of 2 years duration

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No