Testosterone for Peripheral Vascular Disease

Condition(s) targeted: Hypogonadism; Peripheral Vascular Disease; Type 2 Diabetes

Intervention: Testosterone (Drug); 0.9% saline (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Barnsley Hospital

Official(s) and/or principal investigator(s):
T Hugh Jones, Principal Investigator, Affiliation: Barnsley Hospital

Overall contact:
Roger D Stanworth, Phone: 01226 777947, Email: roger.stanworth@nhs.net

There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men. Testosterone treatment has shown beneficial effects on blood sugar control and obesity in pilot studies in men with type 2 diabetes. Beneficial effects have also been seen on angina- a disease related to atherosclerosis (narrowing of the arterial blood vessels). Peripheral vascular disease is also caused by atherosclerosis. We hypothesise that testosterone will have beneficial effects on peripheral vascualr disease in men with low serum testosterone and type 2 diabetes.

Official title: A Randomised, Double Blind, Placebo Controlled, Parallel Pilot Study to Test the Effect of Testosterone Treatment on Peripheral Vascular Disease in Hypogonadal Men With Type 2 Diabetes Mellitus

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Change in arterial stiffness

Secondary outcome:

Change in IMT

Change in transcutaneous oxygen level

Change in ABPI

Change in Walking Impairment Questionnaire

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

1. Type 2 diabetes mellitus.

2. Serum testosterone 12 nmol/L or less on two consecutive samples taken on different days and symptoms compatible with hypogonadism.

3. Peripheral vascular disease as defined by

- previous diagnosis by a specialist vascular surgeon OR

- ABPI less than 0. 92 and ischaemic leg pain (claudication or rest pain) or distal

complications (non-healing arterial foot ulcer or gangrene).

4. Agreement to maintain antihypertensive and antilipid treatments at prior doses during 3 month duration of study.

5. Ability to give written informed consent after verbal and written explanation in the English language.

6. Ability to comply with all study requirements.

Exclusion Criteria:

1. Current or previous breast cancer.

2. Current or previous prostate cancer.

3. Raised prostate specific antigen (PSA) or abnormal per rectal examination unless prostate cancer excluded after specialist urology opinion.

4. Severe symptoms of benign prostatic hypertrophy (‘prostatism’)

5. Treatment with testosterone in the 3 months prior to the trial.

6. Investigational drug treatment in the 3 months prior to the trial.

Roger D Stanworth, Phone: 01226 777947, Email: roger.stanworth@nhs.net

Barnsley Hospital NHS Foundation Trust, Barnsley, South Yorkshire S75 2EP, United Kingdom; Recruiting
Roger D Stanworth, Phone: 01226 777947, Email: roger.stanworth@nhs.net

Starting date: February 2006
Ending date: February 2008
Last updated: July 19, 2007