NCT00349362

Testosterone for Men With Insulin Treated Type 2 Diabetes

A Randomised Double Blind Placebo Controlled, Parallel Pilot Study to Test the Effect of Testosterone Replacement on Glycaemic Control and Arterial Wall Properties of Hypogonadal Men With Type 2 Diabetes Treated With Insulin

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Barnsley Hospital · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test the effect of testosterone treatment on glycaemic control, arterial stiffness and IMT in hypogonadal men with type 2 diabetes treated with insulin.

Detailed description

There is epidemiological data linking low serum testosterone levels in men with the development of diabetes. Clinical trials have indicated a potential benefit of testosterone treatment in improving diabetic control and insulin resistance. Type 2 diabetes is also associated with changes in arterial stiffness and IMT which are known to be linked to the presence of cardiovascular disease. Artificially induced hypogonadism results in increasing arterial stiffness whilst testosterone is known to improve risk factors for vascular disease and act as a vasodilator. The purpose of this pilot study is to test the effect of six months of testosterone replacement, given as testosterone esters 200mg from Sustanon 250 IM injection, on diabetes control in hypogonadal men with type 2 diabetes treated with insulin.

Conditions

• Hypogonadism
• Diabetes

Interventions

Type	Name	Description
DRUG	Testosterone	Sustanon- 200mg intramuscular testosterone
DRUG	0.9% saline	Saline intramuscular injection every two weeks

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2006-07-07
• Last updated: 2010-03-30

Locations

1 site across 1 country: United Kingdom