Testosterone Replacement in Diabetes With Vascular Disease (Version 2)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2009-12-31

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,

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Detailed Description

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Conditions

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Diabetes Mellitus Peripheral Vascular Disease

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

Group Type EXPERIMENTAL

Testosterone

Intervention Type DRUG

Sustanon- intramuscular testosterone 200mg every 2 weeks

Placebo

Group Type PLACEBO_COMPARATOR

0.9% saline

Intervention Type DRUG

Saline injection intramuscular every 2 weeks

Interventions

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Testosterone

Sustanon- intramuscular testosterone 200mg every 2 weeks

Intervention Type DRUG

0.9% saline

Saline injection intramuscular every 2 weeks

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No