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Pioglitazone Therapy in Obese Children With Insulin Resistance: A Randomized, Controlled Pilot Study

NCT00775164 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2012-08-31

No results posted yet for this study

Summary

The primary objective of this study is to examine the effects of four months of pioglitazone vs. metformin treatment on HDL cholesterol, triglycerides, blood pressure, insulin resistance, endothelial function, arterial stiffness, adipokines, oxidative stress, and blood biomarkers of endothelial activation in obese insulin resistant children. 30 obese children with elevated fasting insulin levels will be randomly assigned to pioglitazone or metformin for 16 weeks. Change in clinical variables over the 16-week study period will be compared between groups.

Conditions

Interventions

DRUG

pioglitazone

15 mg per day for 4 weeks, then up-titrated to 30 mg per day for 12 weeks

DRUG

Metformin

Metformin XR; 1000 mg once daily

Sponsors & Collaborators

Principal Investigators

  • Aaron S. Kelly, Ph.D. · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-12-31
Completion
2011-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00775164 on ClinicalTrials.gov