drugset / Trial / NCT00775164
Pioglitazone Therapy in Obese Children With Insulin Resistance: A Randomized, Controlled Pilot Study
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Metformin | Small molecule | 1000 mg | — |
| Subject | Pioglitazone | Small molecule | 30 mg | — |