Testosterone for Peripheral Vascular Disease

Barnsley Hospital

Status and phase: Completed; Phase 4

Conditions: Peripheral Vascular Disease; Type 2 Diabetes; Hypogonadism

Treatments: Drug: Testosterone; Drug: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00504712

300

Details and patient eligibility

About

There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men.

Full description

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.

Enrollment: 24 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

Testosterone 200 mg intramuscular every 2 weeks

Treatment:

Drug: Testosterone

Placebo

Placebo Comparator group

Description:

Saline

Treatment:

Drug: saline