| Trial ID: | L5593 |
| Source ID: | NCT00355537
|
| Associated Drug: |
Testosterone
|
| Title: |
Testosterone Replacement in Diabetes With Vascular Disease (Version 2)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus|Peripheral Vascular Disease
|
| Interventions: |
DRUG: Testosterone|DRUG: 0.9% saline
|
| Outcome Measures: |
Primary: 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: 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
|
| Sponsor/Collaborators: |
Sponsor: Barnsley Hospital
|
| Gender: |
MALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
19
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-02
|
| Completion Date: |
2009-12
|
| Results First Posted: |
|
| Last Update Posted: |
2010-03-30
|
| Locations: |
Barnsley Hospital NHS Foundation Trust, Barnsley, South Yorkshire, S75 2 EP, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT00355537
|
