Back to resultsTestosterone Replacement in Diabetes With Vascular Disease (Version 2)
Primary Purpose
Diabetes Mellitus, Peripheral Vascular Disease
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Testosterone
0.9% saline
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
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
Sites / Locations
- Barnsley Hospital NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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 Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00355537
Brief Title
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
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Barnsley Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Peripheral Vascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Testosterone
Intervention Description
Sustanon- intramuscular testosterone 200mg every 2 weeks
Intervention Type
Drug
Intervention Name(s)
0.9% saline
Intervention Description
Saline injection intramuscular every 2 weeks
Primary Outcome Measure Information:
Title
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The effect of testosterone on intima-media thickness of the femoral artery measured by ultrasound .
Time Frame
3 months
Title
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.
Time Frame
3 months
Title
The effect of testosterone on PVD as measured by ankle-brachial-pressure-indices (ABPI) .
Time Frame
3 months
Title
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.
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugh Jones
Organizational Affiliation
Barnsley Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnsley Hospital NHS Foundation Trust
City
Barnsley
State/Province
South Yorkshire
ZIP/Postal Code
S75 2 EP
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Testosterone Replacement in Diabetes With Vascular Disease (Version 2)
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