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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

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ClinicalTrials.gov Identifier: NCT00964184
Recruitment Status : Completed
First Posted : August 24, 2009
Last Update Posted : August 6, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Metformin Behavioral: Lifestyle modification Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2009
Primary Completion Date : July 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Drug
1 gm metformin per day
Drug: Metformin
control
lifestyle intervention
Behavioral: Lifestyle modification


Outcome Measures

Primary Outcome Measures :
  1. HbA1c [ Time Frame: 18 weeks ]
  2. HbA1C [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Assessment of safety profile of sitagliptin [ Time Frame: 18 weeks ]
  2. insulin [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964184


Locations
India
Fortis Flt Lt Rajan Dhall Hospital
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Diabetes Foundation, India
Investigators
Principal Investigator: Anoop Misra Diabetes Foundation, India
More Information

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
First Posted: August 24, 2009    Key Record Dates
Last Update Posted: August 6, 2015
Last Verified: August 2015

Keywords provided by Dr Anoop Misra, 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