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

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

This study is currently recruiting participants.
Information provided by Stony Brook University

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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

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.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

C-peptide response to a Sustacal meal [ Time Frame: 6 months ]

Secondary Outcome Measure ^†

Insulin requirement [ Time Frame: 6 months ]
Hemoglobin A1c [ Time Frame: 6 months ]

Condition ^†

Type 1 Diabetes Mellitus

Intervention ^†

Drug: pioglitazone
Drug: Placebo control

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

Completion Date

Eligibility 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

Gender

Both

Ages

6 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Thomas` A Wilson, MD

631 689-9703

Thomas.A.Wilson@SUNYSB.EDU

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00545857

Organization ID

20064114

Secondary IDs ^††

Study Sponsor ^†

Stony Brook University

Collaborators ^††

Investigators ^†

Principal Investigator:

Thomas A Wilson, MD

State University of New York, Stony Brook

Information Provided By

Stony Brook University

Verification Date

October 2007

First Received Date ^†

October 16, 2007

Last Updated Date

October 16, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.