Diabetes Mellitus, Type 2
Conditions
Keywords
Maturity onset diabetes of the young 3 protein, human
Brief 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
Interventions
DRUGMetformin
BEHAVIORALLifestyle modification
Sponsors
Diabetes Foundation, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Young (18 to 40 years) patients with diabetes (not on insulin therapy) during the past 6 months and having BMI \<25 kg/m2. * Drug naïve patients * Patients on mono-therapy with metformin (\< 1g/day).
Exclusion criteria
* Type 1 diabetes * Type 2 Diabetes on any other oral hypoglycemic agent other than metformin * Pregnancy or lactation * Insulin or Sulfonylurea treatment within the past 3 months * Has received any investigational drug with the past 60 days * History of prior allergy or hypersensitivity to any drug (unless approved by investigator) * HbA1c \< 7.5% or \> 8.5%. * Unstable glycemic control, requiring addition of 2nd oral agent/insulin or frequent up-titration of dose of metformin. * Any patient on insulin. * Females of child bearing potential who are not using adequate contraception during the study period. * Insulin dependent or history of ketoacidosis requiring hospitalization * Acute infections * Advanced end-organ damage (CLD, CRF etc.) * Diabetes with clinically significant or advanced end-organ damage
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | 18 weeks |
| HbA1C | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of safety profile of sitagliptin | 18 weeks |
| insulin | 12 weeks |
Countries
India
Outcome results
None listed