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A Randomised, Double Blind, Placebo Controlled, Parallel Pilot Study to Test the Effect of Testosterone Treatment on Peripheral Vascular Disease in Hypogonadal Men With Type 2 Diabetes Mellitus
There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men.
Details
| Lead sponsor | Barnsley Hospital |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 24 |
| Start date | 2006-02 |
| Completion | 2009-12 |
Conditions
- Hypogonadism
- Peripheral Vascular Disease
- Type 2 Diabetes
Interventions
- Testosterone
- saline
Primary outcomes
- Change in Arterial Stiffness — Baseline, 12 weeks, and 26 weeks
The primary outcome was the effect of 12 weeks testosterone replacement on arterial stiffness measured by ultrasound derived stiffness parameter β of the femoral artery. A reduction in ultrasound derived stiffness parameter β is clinically beneficial to patients and the study was looking for a reduction in this value. Stiffness index β was calculated from the diastolic carotid artery diameter (Dd), systolic carotid artery diameter (Ds), diastolic blood pressure (BPd) and systolic blood pressure (BPs) using the formula; Stiffness index β = (ln(Ps/Pd)) x Dd/(Ds-Dd). A full theoretical range of possible index scores does not exist.
Countries
United Kingdom