NCT00487734

Effect of Testosterone Replacement on Insulin Resistance

Effect of Testosterone Replacement on Insulin Resistance in Hypogonadal, Non-obese Men With Metabolic Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: McGuire Research Institute · Academic / Other
• Sex: Male
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims to determine whether testosterone replacement improves insulin sensitivity in non-obese men with low testosterone and the metabolic syndrome. The metabolic syndrome includes three of the following five conditions, 1) an elevated blood pressure (greater than 130/85), 2) a triglyceride level greater than 150 mg/dl, 3) an HDL-cholesterol less than 40 mg/dl, 4) glucose levels greater than 100 mg/dl, and 5) a waist measurement greater than 40 inches.

Detailed description

In this proposal, we will examine the relationship between hypogonadism and insulin sensitivity. The strongest relationship between hypogonadism and insulin resistance appears to reside in men with the metabolic syndrome who have a normal BMI. The causal relationship between these two conditions is unknown. Therefore, we propose to determine if testosterone replacement in hypogonadal non-obese men with metabolic syndrome will improve insulin sensitivity. Data obtained from this preliminary investigation, will hopefully result in a hypothesis that can be tested in a larger, more rigorous trial in the future.

Conditions

• Metabolic Syndrome
• Hypogonadism

Interventions

Type	Name	Description
RADIATION	Testosterone gel	testosterone gel, applied daily. Dosed to achieve testosterone level \<500 ng/dL. Possible doses include 2.5g, 5g, 7.5g or 10g gel packets.
DRUG	Placebo for testosterone gel	Placebo gel, 2.5g for each gel packet

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2007-06-19
• Last updated: 2012-10-23

Locations

1 site across 1 country: United States