Testosterone Replacement in Diabetes With Vascular Disease (Version 2)

Study Overview
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Brief Summary
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Diabetes is a major cause of peripheral vascular disease(PVD) and is associated with male hypogonadism. Diabetes and PVD are both associated with arterial stiffness and intima -media thickness which are also related to severity of the clinical syndrome of PVD. Artificially induced hypogonadism results in increasing arterial stiffness whilst testosterone is known to improve risk factors for vascular disease and act as a vasodilator. The purpose of this pilot study is to assess the effect of testosterone treatment on PVD arterial stiffness and intima-media thickness in men with type 2 diabetes and hypogonadism,

Official Title
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A Randomised, Double Blind, Placebo-controlled Parallel 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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Diabetes Mellitus, Peripheral Vascular Disease

Intervention / Treatment
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* Drug: Testosterone
* Drug: 0.9% saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patients greater than 18 years of age Type 2 Diabetes Mellitus Serum testosterone less than 11 nmol/L on two consecutive samples taken on different days Peripheral vascular disease as defined by 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 anti-lipid treatments at prior doses during 3 months 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 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> | Drug: Testosterone<br>* Sustanon- intramuscular testosterone 200mg every 2 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: 0.9% saline<br>* Saline injection intramuscular every 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of testosterone replacement on arterial stiffness measured by ultrasound derived index B of the femoral artery in men with a combination of DM, PVD and hypogonadism. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of testosterone on intima-media thickness of the femoral artery measured by ultrasound . |  | 3 months | 
| The effect of testosterone on peripheral circulation in legs affected by PVD as measured by transcutaneous oxygen saturation in the feet of the study population. |  | 3 months | 
| The effect of testosterone on PVD as measured by ankle-brachial-pressure-indices (ABPI) . |  | 3 months | 
| The effect of testosterone on markers of vascular risk; blood pressure, serum-lipid levels, weight, waist circumference, body fat percentage, urinary micro-albumin concentration and C reactive protein levels. |  | 3 months |