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

NCT ID: NCT05925946

Last Updated: 2023-06-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2026-10-31

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.

Conditions

Diabetes Mellitus; PreDiabetes; Diet Habit

Keywords

Type 2 Diabetes, Low calorie diet, Asian Indians, hepatic fat, pancreatic fat

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

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) :

Group Type: EXPERIMENTAL

CURE-DM

Intervention Type: DIETARY_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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CURE-DM

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Science and Technology, India

OTHER_GOV

Sponsor Role: collaborator

Diabetes Foundation, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Anoop Misra, MD

Role: CONTACT

Phone: 01141759672

Email: anoopmisra@gmail.com

Surya Prakash, PhD+Post Doc

Role: CONTACT

Phone: 01141759672

Email: suryabhat@gmail.com

Other Identifiers

2022-1312

Identifier Type: -

Identifier Source: org_study_id