drugset / Trial / NCT00433173

Insulin Sensitivity in Men With the Metabolic Syndrome

NCT00433173

RandomizedParallel-groupTriple-blindTreatment

Summary

The metabolic syndrome is a medical condition defined by high levels of cholesterol in the blood, high blood pressure, central obesity (gain in fat around the region of the stomach), and insulin resistance (body responds less well to insulin). This state of impaired insulin resistance can lead to type 2 diabetes mellitus, which is one of the most common metabolic disorders in the U.S. Numerous studies have shown an inverse relationship between insulin resistance and testosterone levels in men, however, causality has not been established. This protocol investigates the role of testosterone in modulating insulin sensitivity in insulin resistant states such as the metabolic syndrome. The hypothesis is that testosterone administration will improve insulin sensitivity.

Timeline

Start
2006-05
Primary completion
2011-02
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Anastrozole Other / unclassified 10 mg Oral
Comparator Goserelin Other / unclassified 10.8 mg Other
Comparator Testosterone Small molecule 7.5 g Other

Indications