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Role of Pioglitazone in Preventing Diabetes

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ClinicalTrials.gov Identifier: NCT00276497
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : April 6, 2009
Sponsor:
Collaborator:
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Information provided by:
M.V. Hospital for Diabetes

Brief Summary:
A three year prospective, double blinded, placebo controlled, randomized clinical trial in impaired glucose tolerance (IGT) subjects to study the effect of pioglitazone in preventing the conversion to Diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Drug: Pioglitazone Phase 1

Detailed Description:

A randomized controlled study was designed to find out whether pioglitazone will prevent the conversion to diabetes in subjects who are non obese and with impaired glucose tolerance.

It is a double blind prospective study for 3 years. The study was started in October 2003 and randomization was completed in May 2005. A total of 6643 subjects were screened and 406 were randomized either to pioglitazone or placebo(investigator blinded-groups assigned A and B). At randomisation subjects were given standard advice on diet,exercise and benefits of life style modifications.

Subjects both male and female, aged between 35 and 55 years, with no known history of diabetes, willing and available for a 3 year study alone were screened. Pregnant women, subjects with major illness such as cancer, hepatic or cardiac diseases and on transferable jobs were excluded from the study. The initial dose of tablet was 15mg o.d. which was titrated after a month to 30 mg o.d. in subjects who did not show any adverse events.

The subjects will be undergoing annual reviews with a repeat OGTT, for 3 years. An interim review at every six months is also being done. Proforma containing details of anthropometry, occupation, physical activity, dietary habits, details of medications, regularity of treatment will be done at each interview.

The main expected outcomes of the study will be a reduction in conversion of IGT to diabetes and benefits of the drug on anthropometric variables and biochemical parameters.


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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Study Start Date : October 2003
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Reduction in conversion of IGT to diabetes

Secondary Outcome Measures :
  1. benefits of the drug on anthropometric variables and biochemical parameters


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Both male and female
  • Age 35 - 55 years
  • No known history of diabetes
  • Willing and available for a 3 years study

Exclusion Criteria:

  • Pregnant women
  • Subjects with major illness such as cancer, hepatic or cardiac diseases
  • Transferable jobs

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): NCT00276497


Sponsors and Collaborators
M.V. Hospital for Diabetes
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Investigators
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Principal Investigator: Ambady Ramachandran, MD,PhD,DSc India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes hospitals, 28, Marshall's Road, Egmore, Chennai-600 008. India

Publications of Results:
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ClinicalTrials.gov Identifier: NCT00276497     History of Changes
Other Study ID Numbers: IDPP2
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: April 6, 2009
Last Verified: April 2009
Keywords provided by M.V. Hospital for Diabetes:
Impaired glucose tolerance
Intervention
Prevention
Additional relevant MeSH terms:
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Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs