A Randomised Double Blind Placebo Controlled, Parallel Pilot Study to Test the Effect of Testosterone Replacement on Glycaemic Control and Arterial Wall Properties of Hypogonadal Men With Type 2 Diabetes Treated With Insulin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The effect of 6 months of testosterone replacement on diabetes control measured by HbA1c in hypogonadal men with type 2 diabetes treated with insulin.
研究概览
简要总结
The purpose of this study is to test the effect of testosterone treatment on glycaemic control, arterial stiffness and IMT in hypogonadal men with type 2 diabetes treated with insulin.
详细描述
There is epidemiological data linking low serum testosterone levels in men with the development of diabetes. Clinical trials have indicated a potential benefit of testosterone treatment in improving diabetic control and insulin resistance. Type 2 diabetes is also associated with changes in arterial stiffness and IMT which are known to be linked to the presence of cardiovascular disease. 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 test the effect of six months of testosterone replacement, given as testosterone esters 200mg from Sustanon 250 IM injection, on diabetes control in hypogonadal men with type 2 diabetes treated with insulin.
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
- Double
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •males over 40 years old
- •type 2 diabetes treated with insulin
- •serum testosterone less than 12nmol/L on 2 consecutive morning samples
- •symptoms attributable to hypogonadism
排除标准
- •current or previous breast cancer
- •current or previous prostate cancer
- •raised prostate specific antigen or abdominal digital rectal examination suspicious of prostate cancer unless diagnosis excluded after specialist urology opinion and/or prostate biopsy
- •severe symptoms of benign prostatic hypertrophy
- •treatment with testosterone in the three months prior to the trial
- •investigational drug treatment in the three months prior to the trial
研究组 & 干预措施
Testosterone
Testosterone injections- 200mg- every 2 weeks
干预措施: Testosterone (Drug)
Placebo
Normal saline injections- every two weeks
干预措施: 0.9% saline (Drug)
结局指标
主要结局
The effect of 6 months of testosterone replacement on diabetes control measured by HbA1c in hypogonadal men with type 2 diabetes treated with insulin.
时间窗: 6 months
次要结局
- The effect of testosterone on ultrasound measured intima-media thickness of the common carotid artery in the study population(6 months)
- The effect of testosterone on male hypogonadism as assessed by the Ageing Males Symptoms (AMS)(6 months)
- The effect of testosterone on markers of vascular risk; blood pressure, serum lipid levels, weight, waist circumference, body fat percentage,(6 months)
- urinary micro-albumin, tumour necrosis factor alpha, and highly sensitive C reactive protein levels in the study population.(6 months)
- The effect of the CAG repeat polymorphism in exon 1 of the androgen receptor gene on the response of the study population to testosterone.(6 months)