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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
133
Fortis Flt Lt Rajan Dhall Hospital
New Delhi, National Capital Territory of Delhi, India
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.