Diabetes Mellitus, Type 2 Clinical Trial
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:
- 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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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