NCT00964184

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Diabetes Foundation, India · Academic / Other
• Sex: All
• Age: 14 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

A phase IV on T2DM with BMI \< 25 kg/m2 and age 14-40 years. Primary Objectives: * 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). Secondary Objectives: * 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

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Metformin
BEHAVIORAL	Lifestyle modification

Timeline

• Start date: 2009-09-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2009-08-24
• Last updated: 2015-08-06

Locations

1 site across 1 country: India