NCT00355537

Testosterone Replacement in Diabetes With Vascular Disease (Version 2)

A Randomised, Double Blind, Placebo-controlled Parallel Study to Test the Effect of Testosterone Treatment on Peripheral Vascular Disease in Hypogonadal Men With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Barnsley Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Diabetes is a major cause of peripheral vascular disease(PVD) and is associated with male hypogonadism. Diabetes and PVD are both associated with arterial stiffness and intima -media thickness which are also related to severity of the clinical syndrome of PVD. 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 assess the effect of testosterone treatment on PVD arterial stiffness and intima-media thickness in men with type 2 diabetes and hypogonadism,

Conditions

• Diabetes Mellitus
• Peripheral Vascular Disease

Interventions

Type	Name	Description
DRUG	Testosterone	Sustanon- intramuscular testosterone 200mg every 2 weeks
DRUG	0.9% saline	Saline injection intramuscular every 2 weeks

Timeline

• Start date: 2006-02-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2006-07-24
• Last updated: 2010-03-30

Locations

1 site across 1 country: United Kingdom