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

Diabetes Mellitus Clinical Trial

— CURE-DM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05925946
• Other study ID #: 2022-1312
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 31, 2026

Study information

• Verified date: June 2023
• Source: Diabetes Foundation, India
• Contact: Anoop Misra, MD
• Phone: 01141759672
• Email: anoopmisra[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 31, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diet Habit
• PreDiabetes

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Diabetes Foundation, India	Ministry of Science and Technology, India

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Muscle strength	Handgrip muscle strength by Jamar Dynamometer	24 Months
Secondary	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
Secondary	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
Secondary	Body fat	Body fat will be done by Whole body dual-energy X-ray absorptiometry (DEXA scan	24 Months
Secondary	Insulin Resistance	Surrogate markers of insulin sensitivity	24 Months