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. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014