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Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus

This study is currently recruiting participants.
Verified by Stony Brook University, October 2007

Sponsored by: Stony Brook University
Information provided by: Stony Brook University
ClinicalTrials.gov Identifier: NCT00545857
  Purpose

A study to examine the effect of pioglitazone on the course of new onset type 1 diabetes mellitus.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: pioglitazone
Drug: Placebo control
Phase I

MedlinePlus related topics:   Diabetes   Diabetes Type 1  

ChemIDplus related topics:   Insulin   Pioglitazone   Pioglitazone hydrochloride  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus

Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • C-peptide response to a Sustacal meal [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Insulin requirement [ Time Frame: 6 months ]
  • Hemoglobin A1c [ Time Frame: 6 months ]

Arms Assigned Interventions
Pioglitazone: Experimental Drug: pioglitazone
Placebo control: Placebo Comparator Drug: Placebo control

Detailed Description:

Thiazolidinediones have been shown to reduce the development of diabetes mellitus in animal models of type 1 diabetes and to reduce the death of beta cells (cells that make insulin) in petri dishes. Pioglitazone is a thiazolidinedione currently approved for the treatment of type 2 diabetes. This study explores the question of whether pioglitazone can preserve beta cell function in patients with recently diagnosed type 1 diabetes mellitus.

  Eligibility
Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patients with type 1 diabetes mellitus diagnosed within 4 months
  • Age > 6 years of age
  • Ability to swallow capsule
  • Signed informed consent / assent

Exclusion Criteria:

  • Other illnesses
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545857

Contacts
Contact: Thomas` A Wilson, MD     631 689-9703     Thomas.A.Wilson@SUNYSB.EDU    

Locations
United States, New York
GCRC / Stony Brook University Hospital     Recruiting
      Stony Brook, New York, United States, 11794-8111
      Principal Investigator: Thomas A Wilson, MD            
      Sub-Investigator: Andrew H. Lane, MD            

Sponsors and Collaborators
Stony Brook University

Investigators
Principal Investigator:     Thomas A Wilson, MD     State University of New York, Stony Brook    
  More Information

Study ID Numbers:   20064114
First Received:   October 16, 2007
Last Updated:   October 16, 2007
ClinicalTrials.gov Identifier:   NCT00545857
Health Authority:   United States: Institutional Review Board

Keywords provided by Stony Brook University:
Type 1 diabetes  
Insulin dependent diabetes  
Juvenile onset diabetes  
pioglitazone  

Study placed in the following topic categories:
Autoimmune Diseases
Pioglitazone
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:
Hypoglycemic Agents
Metabolic Diseases
Immune System Diseases
Physiological Effects of Drugs
Endocrine System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 03, 2008




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