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

This study is currently recruiting participants.
Verified February 2014 by Diabetes Foundation, India
Sponsor:
Information provided by (Responsible Party):
Dr Anoop Misra, Diabetes Foundation, India
ClinicalTrials.gov Identifier:
NCT00964184
First received: August 21, 2009
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Metformin
Drug: Placebo
Behavioral: Lifestyle Modification
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Diabetes Foundation, India:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • HbA1C [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Assessment of safety profile of sitagliptin [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]
  • insulin [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: September 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Metformin
    less than 1 gram per day
    Drug: Placebo
    less than 1 gram per day
    Behavioral: Lifestyle Modification
    Lifestyle modification
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
  Eligibility

Ages Eligible for Study:   14 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964184

Contacts
Contact: Anoop Misra +91-11-42776222 ext 5030 anoopmisra@gmail.com

Locations
India
Fortis Flt Lt Rajan Dhall Hospital Recruiting
New Delhi, Delhi, India, 110070
Contact: Anoop Misra    +91-11-42776222 ext 5030    anoopmisra@gmail.com   
Principal Investigator: Anoop Misra         
Sponsors and Collaborators
Diabetes Foundation, India
  More Information

No publications provided

Responsible Party: Dr Anoop Misra, Director, Diabetes, Obesity and Metabolic Disorders, Diabetes Foundation, India
ClinicalTrials.gov Identifier: NCT00964184     History of Changes
Other Study ID Numbers: LeanDM-01
Study First Received: August 21, 2009
Last Updated: February 4, 2014
Health Authority: India: Institutional Review Board

Keywords provided by Diabetes Foundation, India:
Maturity onset diabetes of the young 3 protein, human

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014