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NCT Number: NCT05925946

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

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.

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Key information

Conditions

Diabetes Mellitus Behavior Behavior, Animal Diabetes Mellitus, Type 2 Diet Habit Endocrine System Diseases Feeding Behavior Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases PreDiabetes Prediabetic State

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CURE-DM

Dietary Supplement
  • 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.

Primary outcomes

  1. Reversal of diabetes

    Time frame: 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 outcomes

  1. Muscle strength

    Time frame: 24 Months

    Handgrip muscle strength by Jamar Dynamometer

  2. Anthropometric assessment

    Time frame: 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)

  3. Hepatic and Pancreatic Fat

    Time frame: 24 Months

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

  4. Body fat

    Time frame: 24 Months

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

  5. Insulin Resistance

    Time frame: 24 Months

    Surrogate markers of insulin sensitivity

Study contacts

Contact information is provided by the study sponsor or research team.

Anoop Misra, MD

CONTACT

[email protected]

01141759672

Surya Prakash, PhD+Post Doc

CONTACT

[email protected]

01141759672

Sponsors and collaborators

Lead sponsor

Diabetes Foundation, India

Other

Collaborators

  • Ministry of Science and Technology, India

Registry information

Official study 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

Acronym: CURE-DM

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2023
Registry last updated
Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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