Effect of Testosterone on Endothelial Function and Microcirculation in Type 2 Diabetic Patients With Hypogonadism
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. The investigators 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). The investigators hope to demonstrate an improvement in endothelial dysfunction by assessing biochemical markers such as nitric oxide (a chemical that causes relaxation for the blood vessels) 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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase IV: Effect of Testosterone on Endothelial Function and Microcirculation in Type 2 Diabetic Patients With Hypogonadism|
- Improvement in endothelial dependent and endothelial-independent vasodilatation [ Time Frame: 30 and 54 weeks ] [ Designated as safety issue: No ]
- Markers of endothelial function [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
Secondary efficacy variables will include changes of the following
- Availability of nitric oxide
- Endothelial inflammation as measured by CRP
- Serum levels of endothelial markers: IGF and adhesion molecules
- BMI, waist circumference, glycaemic control (HbA1c), lipid profile and blood pressure.
- Other laboratory parameters
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: Testosterone, Vardenafil
All patients will receive Testosterone (n=40) of these (10 patients) will also receive Vardenafil
NEBIDO ampoules containing a solution for injection of 1000mg/4ml of testosterone undecanoate. NEBIDO injection 1000mg/4ml will be given at baseline, 6 weeks, 18 weeks, 30 weeks, 42 and 54 weeks. Levitra will be given to those patients with erectile dysfunction for 2 weeks in addition to Nebido.
Concomitant medication deemed necessary by the investigator as part of the routine clinical management will be permissable.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084369
|Contact: Edward Jude, MD, MRCPfirstname.lastname@example.org|
|Tameside General Hospital||Recruiting|
|Ashton-under-Lyne, Lancashire, United Kingdom, OL6 9RW|
|Tameside Hospital NHS Foundatoin Trust||Recruiting|
|Ashton under Lyne, United Kingdom, OL69RW|
|Principal Investigator:||Edward Jude, MD, MRCP||Tameside Hospital NHS Foundation Trust|