Phenotypic and Genetic Correlates of Diabetes (Non-Type 1) in Young Non-Obese Asian Indians in North India and A Pilot Case Control Study to Evaluate the Efficacy of Sitagliptin (DPP-4 Inhibitor) in a Sub-group of the Study Population
Recruitment status was Recruiting
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.
Diabetes Mellitus, Type 2
Behavioral: Lifestyle Modification
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
- Change of HbA1c from baseline at the end of 18 weeks in the drug group as compared to placebo [ Time Frame: At baseline, 6 weeks, 12 weeks and 18 weeks ] [ Designated as safety issue: No ]
- Change in HbA1c, blood glucose, pro-insulin, insulin and C-Peptide (F/ PP) at end of 6 and 12 weeks [ Time Frame: At 6 and 12 weeks ] [ Designated as safety issue: Yes ]
- Change in body weight, serum lipids at 18 weeks [ Time Frame: At 18 weeks ] [ Designated as safety issue: Yes ]
- Assessment of safety profile of sitagliptin [ Time Frame: At 6 ,12 and 18 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
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
|Contact: Anoop Misra||+91-11-42776222 ext email@example.com|
|Fortis Flt Lt Rajan Dhall Hospital||Recruiting|
|New Delhi, Delhi, India, 110070|
|Contact: Anoop Misra +91-11-42776222 ext 5030 firstname.lastname@example.org|
|Principal Investigator: Anoop Misra|