drugset / Trial / NCT00775164

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

NCT00775164

Phase 4 Withdrawn University of Minnesota
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2009-01
Primary completion
2010-12
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 1000 mg
Subject Pioglitazone Small molecule 30 mg

Indications