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

NCT ID: NCT00545857

Last Updated: 2012-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2012-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Type 1 Diabetes Mellitus

Keywords

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Type 1 diabetes Insulin dependent diabetes Juvenile onset diabetes pioglitazone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pioglitazone

Group Type EXPERIMENTAL

pioglitazone

Intervention Type DRUG

Pioglitazone daily; dose varies with size

Placebo control

Intervention Type DRUG

Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus

Placebo control

Group Type PLACEBO_COMPARATOR

pioglitazone

Intervention Type DRUG

Pioglitazone daily; dose varies with size

Placebo control

Intervention Type DRUG

Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus

Interventions

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pioglitazone

Pioglitazone daily; dose varies with size

Intervention Type DRUG

Placebo control

Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus

Intervention Type DRUG

Other Intervention Names

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Actos Actos

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Thomas A. Wilson

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas A Wilson, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York Stony Brook

Locations

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Thomas A. Wilson, MD

Stony Brook, New York, United States

Site Status

Countries

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United States

References

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Tafuri KS, Godil MA, Lane AH, Wilson TA. Effect of pioglitazone on the course of new-onset type 1 diabetes mellitus. J Clin Res Pediatr Endocrinol. 2013;5(4):236-9. doi: 10.4274/Jcrpe.981.

Reference Type DERIVED
PMID: 24379032 (View on PubMed)

Other Identifiers

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20064114

Identifier Type: -

Identifier Source: org_study_id