Clinical trial NCT00355537: Testosterone Replacement in Diabetes With Vascular Disease (Version 2)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Peripheral Vascular Disease
Lead sponsor: Barnsley Hospital
Sponsor class: OTHER
First posted: 2006-07-24
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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,


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 3 months
Secondary outcomes:
measure: The effect of testosterone on intima-media thickness of the femoral artery measured by ultrasound .
timeFrame: 3 months
measure: 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.
timeFrame: 3 months
measure: The effect of testosterone on PVD as measured by ankle-brachial-pressure-indices (ABPI) .
timeFrame: 3 months
measure: 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.
timeFrame: 3 months
Other outcomes:
Locations:
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital NHS Foundation Trust
state: South Yorkshire
Study officials:
affiliation: Barnsley Hospital NHS Foundation Trust
name: Hugh Jones
role: PRINCIPAL_INVESTIGATOR
References: