Phenotypic and Genetic Correlates of Diabetes (Non-Type 1) in Young Non-Obese Asian Indians in North India and A Study to Evaluate the Efficacy of Sitagliptin (DPP-4 Inhibitor) in a Sub-group of the Study Population
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|ClinicalTrials.gov Identifier: NCT00964184|
Recruitment Status : Completed
First Posted : August 24, 2009
Last Update Posted : August 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Metformin Behavioral: Lifestyle modification||Phase 4|
A phase IV on T2DM with BMI < 25 kg/m2 and age 14-40 years.
- To investigate phenotype (body composition, anthropometry, pancreatic imaging and endocrine function, insulin resistance, autoantibodies, and other biochemical variables) and genetic (known mutations and polymorphisms) correlates in young (age 14-40 years) diabetic patients (non-type 1).
- To study anthropometric and body fat distribution including truncal fat, subcutaneous and intra-abdominal fat in non-obese young patients with diabetes (non-type 1).
- To study whether insulin secretion, insulin resistance or a combination of both is/are the predominant defect(s) in non-obese young diabetics (non-type 1).
- To study the prevalence of autoimmunity and/or specific genetic abnormalities in this subgroup of diabetics.
- To estimate approximate prevalence of diagnostic subcategories based on the sample of population, and profile of complications in each category.
- To propose rational use of specialized investigations (e.g. GAD65, HNF-1α mutations etc) while investigating a newly diagnosed young diabetic.
- To determine the rational therapeutic option and prognosis in this sub-population of diabetics based on anthropometric, biochemical, and etiological profiles.
- Sample size: 205 patients to be enrolled and 120 patients to be enrolled for sub group study
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||133 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
1 gm metformin per day
Behavioral: Lifestyle modification
- HbA1c [ Time Frame: 18 weeks ]
- HbA1C [ Time Frame: 12 weeks ]
- Assessment of safety profile of sitagliptin [ Time Frame: 18 weeks ]
- insulin [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964184
|Fortis Flt Lt Rajan Dhall Hospital|
|New Delhi, Delhi, India, 110070|
|Principal Investigator:||Anoop Misra||Diabetes Foundation, India|