Hypogonadism and Endothelial Dysfunction in Type 2 Diabetes.
Research type
Research Study
Full title
Effect of Testosterone on endothelial function and Microcirculation in Type 2 Diabetic patients with Hypoganadism.
IRAS ID
61199
Contact name
Edward Jude
Eudract number
2010-020018-27
Clinicaltrials.gov Identifier
Research summary
Diabetes mellitus is associated with long-term complications affecting mainly the eyes, nerves and kidneys. One of the main underlying causes for this is damage to the lining of the small blood vessels supplying these organs with dysfunction of the endothelium (lining of the small blood vessels). Testosterone has been shown to have an effect macro (large) blood vessels with limited data available on the micro (small) blood vessels. Testosterone is recognised to have important effects on metabolism and vascular behaviour beyond the accepted effects on secondary sexual characteristics. Physiological testosterone therapy is associated with some beneficial effects on the cardiovascular system and has been used with some success to treat patients with stable angina and chronic heart failure. We therefore propose to study the effects of testosterone replacement therapy in patients with hypogonadism (low testosterone levels) on the endothelium in males with type 2 diabetes. 40 diabetic patients with type 2 diabetes and low testosterone levels and erectile dysfunction (impotence) will be recruited into the study. All patients will receive testosterone replacement therapy and 10 patients will also receive Vardenafil (a drug used to treat impotence). We hope to demonstrate an improvement in endothelial dysfunction by assessing biochemical markers such as nitric oxide (a chemical that causes relaxation fo the blood vessles) and C-reactive protein (a chemical that can increase in patients with diabetes) as well as the effect on weight, blood pressure, diabetes control and cholesterol.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
11/NW/0533
Date of REC Opinion
7 Nov 2011
REC opinion
Further Information Favourable Opinion