Testosterone Replacement in Diabetes With Vascular Disease (Version 2)
NCT00355537 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2010-03-30
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,
Conditions
- Diabetes Mellitus
- Peripheral Vascular Disease
Interventions
- DRUG
-
Testosterone
Sustanon- intramuscular testosterone 200mg every 2 weeks
- DRUG
-
0.9% saline
Saline injection intramuscular every 2 weeks
Sponsors & Collaborators
-
Barnsley Hospital
lead OTHER
Principal Investigators
-
Hugh Jones · Barnsley Hospital NHS Foundation Trust
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-02-28
- Primary Completion
- 2009-12-31
- Completion
- 2009-12-31
Countries
- United Kingdom
Study Locations
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