There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men.
Testosterone treatment has shown beneficial effects on blood sugar control and obesity in pilot studies in men with type 2 diabetes. Beneficial effects have also been seen on angina- a disease related to atherosclerosis (narrowing of the arterial blood vessels). Peripheral vascular disease is also caused by atherosclerosis. We hypothesise that testosterone will have beneficial effects on peripheral vascualr disease in men with low serum testosterone and type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
Sustanon- 200mg- Intramuscular testosterone every 2 weeks
Saline injection every two weeks
Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire, United Kingdom
Change in Arterial Stiffness
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.
Time frame: Baseline, 12 weeks, and 26 weeks
Change in IMT
Progression of Carotid intima-media thickness measured in mm
Time frame: Baseline, 12 weeks, and 26 weeks
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