Testosterone Replacement in Diabetes With Vascular Disease (Version 2)
Information source: Barnsley Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus; Peripheral Vascular Disease
Intervention: Testosterone (Drug); 0.9% saline (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Barnsley Hospital Official(s) and/or principal investigator(s):
Hugh Jones, Principal Investigator, Affiliation: Barnsley Hospital NHS Foundation Trust
Overall contact:
Hugh Jones, BSc MD FRCP, Phone: 01226 777947, Email: Hugh.Jones@nhs.net
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,
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: The effect of testosterone on intima-media thickness of the femoral artery measured by ultrasound .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. The effect of testosterone on PVD as measured by ankle-brachial-pressure-indices (ABPI) . 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Hugh Jones, BSc MD FRCP, Phone: 01226 777947, Email: Hugh.Jones@nhs.net
Barnsley Hospital NHS Foundation Trust, Barnsley, South Yorkshire S75 2 EP, United Kingdom; Recruiting
Hugh Jones, Principal Investigator
Roger Stanworth, Sub-Investigator
Additional Information
Starting date: February 2006
Ending date: February 2008
Last updated: July 19, 2007
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