Testosterone for Peripheral Vascular Disease

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

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.

Official Title
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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

Conditions
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Hypogonadism, Peripheral Vascular Disease, Type 2 Diabetes

Intervention / Treatment
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* Drug: Testosterone
* Drug: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus. Serum testosterone 12 nmol/L or less on two consecutive samples taken on different days and symptoms compatible with hypogonadism. 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). Agreement to maintain antihypertensive and antilipid treatments at prior doses during 3 month duration of study. Ability to give written informed consent after verbal and written explanation in the English language. Ability to comply with all study requirements. Exclusion Criteria: Current or previous breast cancer. Current or previous prostate cancer. Raised prostate specific antigen (PSA) or abnormal per rectal examination unless prostate cancer excluded after specialist urology opinion. Severe symptoms of benign prostatic hypertrophy ('prostatism') Treatment with testosterone in the 3 months prior to the trial. Investigational drug treatment in the 3 months prior to the trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Testosterone 200 mg intramuscular every 2 weeks | Drug: Testosterone<br>* Sustanon- 200mg- Intramuscular testosterone every 2 weeks<br>|
| Placebo Comparator: Placebo<br>Saline | Drug: saline<br>* Saline injection every two weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Arterial Stiffness | The primary outcome was the effect of 12 weeks testosterone replacement on arterial stiffness measured by ultrasound derived stiffness parameter β of the femoral artery. A reduction in ultrasound derived stiffness parameter β is clinically beneficial to patients and the study was looking for a reduction in this value. Stiffness index β was calculated from the diastolic carotid artery diameter (Dd), systolic carotid artery diameter (Ds), diastolic blood pressure (BPd) and systolic blood pressure (BPs) using the formula; Stiffness index β = (ln(Ps/Pd)) x Dd/(Ds-Dd). A full theoretical range of possible index scores does not exist. | Baseline, 12 weeks, and 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in IMT | Progression of Carotid intima-media thickness measured in mm | Baseline, 12 weeks, and 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Testosterone, Hypogonadism, Diabetes, PVD, RCT