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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Arterial Stiffness
研究概览
简要总结
There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus.
- •Serum testosterone 12 nmol/L or less on two consecutive samples taken on different days and symptoms compatible with hypogonadism.
- •Peripheral vascular disease as defined by
- •previous diagnosis by a specialist vascular surgeon OR
- •ABPI less than 0.92 and ischaemic leg pain (claudication or rest pain) or distal complications (non-healing arterial foot ulcer or gangrene).
- •Agreement to maintain antihypertensive and antilipid treatments at prior doses during 3 month duration of study.
- •Ability to give written informed consent after verbal and written explanation in the English language.
- •Ability to comply with all study requirements.
排除标准
- •Current or previous breast cancer.
- •Current or previous prostate cancer.
- •Raised prostate specific antigen (PSA) or abnormal per rectal examination unless prostate cancer excluded after specialist urology opinion.
- •Severe symptoms of benign prostatic hypertrophy ('prostatism')
- •Treatment with testosterone in the 3 months prior to the trial.
- •Investigational drug treatment in the 3 months prior to the trial.
研究组 & 干预措施
Active
Testosterone 200 mg intramuscular every 2 weeks
干预措施: Testosterone (Drug)
Placebo
Saline
干预措施: saline (Drug)
结局指标
主要结局
Change in Arterial Stiffness
时间窗: 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.
次要结局
- Change in IMT(Baseline, 12 weeks, and 26 weeks)