Effect of Androgel on Atherogenesis, Inflammation, Cardiovascular Risk Factors And Adiposity in Type 2 Diabetic Males With Hypogonadotrophic Hypogonadism.: a Prospective, Randomized and Controlled-Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Carotid Intima Media Thickness
研究概览
简要总结
The purpose of this study is to examine the effects of testosterone deficiency in men with diabetes on atherogenesis, inflammation, cardiovascular Risk factors And adiposity .
详细描述
The purpose of this study is to examine the effects of testosterone deficiency in men with diabetes on atherogenesis, inflammation, cardiovascular Risk factors And adiposity . This will be done by comparing the changes in several body response indicators following treatment with testosterone in diabetic men with low testosterone levels and comparing them to diabetic men with low testosterone who are not treated with testosterone. These groups will also be compared with diabetic men who have normal testosterone levels
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 (Participant, Investigator)
盲法说明
matching placebo
入排标准
- 年龄范围
- 31 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males with age 30-60 years inclusive.
- •PSA < 2.6 ng/ml or < 3.75 ng/ml with a negative prostate biopsy in the last 6 months.
- •The lower age limit was decided on the fact that in our study on hypogonadotrophic hypogonadism in type 2 diabetic patients, the youngest subject was 31 years old. The upper age limit has been restricted to 60 to avoid including subjects with significant age-related declines in testosterone concentrations.Subjects on thiazolidinediones, statins, ACE inhibitors, angiotensin receptor blockers or antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the study. Subjects on insulin, metformin or sulfonylureas can participate in the study, provided that minimal changes are made to the doses during the study
排除标准
- •Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks; 2)Hemoglobin A1c >10%;
- •h/o prostate carcinoma;
- •Hepatic disease (transaminase > 3 times normal) or cirrhosis;
- •Renal impairment (serum creatinine > 1.5);
- •HIV or Hepatitis C positive status;
- •Participation in any other concurrent clinical trial;
- •Any other life-threatening, non-cardiac disease;
- •Use of over the counter health supplements which contain androgens;
- •Use of an investigational agent or therapeutic regimen within 30 days of study.
- •Use of testosterone in the past
- •Hematocrit > 50%.
研究组 & 干预措施
androgel
androgel
干预措施: androgel (Drug)
placebo
placebo gel
干预措施: placebo (Drug)
结局指标
主要结局
Carotid Intima Media Thickness
时间窗: 2 years
carotid intima media thickness measured at baseline 0 months and at 2 years in centimeters (cm).
次要结局
- Endothelial Function(2 years)
研究者
Paresh Dandona
MD
University at Buffalo