Testosterone for Peripheral Vascular Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2009-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hypogonadism Peripheral Vascular Disease Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active

Testosterone 200 mg intramuscular every 2 weeks

Group Type EXPERIMENTAL

Testosterone

Intervention Type DRUG

Sustanon- 200mg- Intramuscular testosterone every 2 weeks

Placebo

Saline

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

Saline injection every two weeks

Interventions

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Testosterone

Sustanon- 200mg- Intramuscular testosterone every 2 weeks

Intervention Type DRUG

saline

Saline injection every two weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No