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

August 5, 2015 updated by: Dr Anoop Misra, Diabetes Foundation, India
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Fortis Flt Lt Rajan Dhall Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug
1 gm metformin per day
Drug: Metformin
Other: control
lifestyle intervention
Behavioral: Lifestyle modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 18 weeks
18 weeks
HbA1C
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of safety profile of sitagliptin
Time Frame: 18 weeks
18 weeks
insulin
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diabetes Foundation, India

Investigators

  • Principal Investigator: Anoop Misra, Diabetes Foundation, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

August 21, 2009

First Submitted That Met QC Criteria

August 21, 2009

First Posted (Estimate)

August 24, 2009

Study Record Updates

Last Update Posted (Estimate)

August 6, 2015

Last Update Submitted That Met QC Criteria

August 5, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LeanDM-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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