Testosterone Replacement in Diabetes With Vascular Disease (Version 2)
This study has been completed.
Sponsor:
Barnsley Hospital
Information provided by:
Barnsley Hospital
ClinicalTrials.gov Identifier:
NCT00355537
First received: July 21, 2006
Last updated: March 29, 2010
Last verified: March 2010
Tracking Information | |||||
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First Received Date ICMJE | July 21, 2006 | ||||
Last Updated Date | March 29, 2010 | ||||
Start Date ICMJE | February 2006 | ||||
Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
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. | ||||
Change History | Complete list of historical versions of study NCT00355537 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Testosterone Replacement in Diabetes With Vascular Disease (Version 2) | ||||
Official Title ICMJE | 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 | ||||
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, |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 19 | ||||
Completion Date | December 2009 | ||||
Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00355537 | ||||
Other Study ID Numbers ICMJE | BDGH 237 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Prof Hugh Jones, Barnsley Hospital | ||||
Study Sponsor ICMJE | Barnsley Hospital | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Barnsley Hospital | ||||
Verification Date | March 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |