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

Diabetes Foundation, India

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Metformin

Behavioral: Lifestyle modification

Study type

Interventional

Funder types

Other

Identifiers

NCT00964184

LeanDM-01

Details and patient eligibility

About

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.

Full 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

Enrollment

133 patients

Sex

All

Ages

14 to 40 years old

Volunteers

No Healthy Volunteers

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