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| Name | Class |
|---|---|
| Ministry of Science and Technology, India | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental |
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| Control Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CURE-DM | Dietary Supplement |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anoop Misra, MD | Contact | 01141759672 | anoopmisra@gmail.com | |
| Surya Prakash, PhD+Post Doc | Contact | 01141759672 | suryabhat@gmail.com |
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This randomized controlled prospective trial will be of 2 years duration
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D011236 | Prediabetic State |
| D005247 | Feeding Behavior |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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 |
| D001522 | Behavior, Animal |
| D001519 | Behavior |