Testosterone Replacement in Diabetes With Vascular Disease (Version 2)

Phase 4

Completed

• Conditions: Diabetes Mellitus; Peripheral Vascular Disease
• Interventions: Drug: 0.9% saline; Drug: Testosterone

• Registration Number: NCT00355537
• Lead Sponsor: Barnsley Hospital

Brief Summary

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,

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-07-21
• Study First Submitted QC: 2006-07-21
• Study First Posted: 2006-07-24
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-29
• Last Update Posted: 2010-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	0.9% saline	-
Active	Testosterone	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Barnsley Hospital NHS Foundation Trust; 🇬🇧 Barnsley, South Yorkshire, United Kingdom