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This is a phase IV study of 3.5 years duration to evaluate the phenotypic and genetic correlates of diabetes (non-Type 1 in young non-obese Asian Indians in North India and pilot case control study to evaluate the efficacy of sitagliptin (DPP-4 inhibitor) in a sub-group of the study population.
A phase IV on T2DM with BMI < 25 kg/m2 and age 14-40 years.
Primary Objectives:
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug | Experimental | 1 gm metformin per day |
|
| control | Other | lifestyle intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug |
| ||
| Lifestyle modification |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | 18 weeks | |
| HbA1C | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of safety profile of sitagliptin | 18 weeks | |
| insulin | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anoop Misra | Diabetes Foundation, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortis Flt Lt Rajan Dhall Hospital | New Delhi | National Capital Territory of Delhi | 110070 | India |
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|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| C563933 | Maturity-Onset Diabetes of the Young, Type 3 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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