Effect of Low-Calorie Diet and Lifestyle Intervention on Reversal of T2DM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CURE-DM.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, PreDiabetes, Diet Habit. Basic parameters: 20 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
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.
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.
Interventions
- Dietary supplement 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.
Primary outcome measures
- Reversal of diabetes [Time frame: 24 Months]
Secondary outcome measures (5)
- Muscle strength [Time frame: 24 Months]
- Anthropometric assessment [Time frame: 24 Months]
- Hepatic and Pancreatic Fat [Time frame: 24 Months]
- Body fat [Time frame: 24 Months]
- Insulin Resistance [Time frame: 24 Months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05925946 · 2022-1312