Effect of Androgel on Inflammatory Mediators and Oxidative Stress in Type 2 Diabetic Males With Hypogonadism
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo
研究概览
简要总结
This is to study the effect of replacing testosterone on different inflammatory cells in type 2 diabetics with low testosterone levels.
详细描述
Type 2 diabetes is an atherosclerotic, pro-inflammatory and pro-oxidative stress. Hypogonadism( low testosterone) is also associated with increased levels of inflammatory mediators and atherosclerosis.
This project is about studying the effect of testosterone replacement on different inflammatory cells in blood and urine. It will also compare the dose dependent effect on inflammatory cells. This also involves comparing level of inflammation in hypogonadic diabetic males treated with testosterone with those not treated with any replacement therapy.
This study involves applying AndroGel for 8 wks and studying effects during this time and thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males with age 35-75 years inclusive.
- •Evidence of hypogonadism: low free testosterone.
- •Type 2 Diabetes
- •People on stable doses of cholesterol lowering medications, blood pressure medications and multi-vitamins are allowed.
- •If currently on testosterone replacement,testosterone treatment will be held for 8 weeks.
- •BP under control even if on medication.
排除标准
- •Coronary event or procedure in previous past 4 wks.
- •H/O prostate cancer
- •Hepatic or renal disease
- •Participation in any other concurrent clinical trial
- •Any other life- threatening , non cardiac disease.
- •Uncontrolled BP
- •Congestive heart failure
- •High hemoglobin
- •Use of investigational agent or therapeutic regimen within 30 days of study.
研究组 & 干预措施
placebo
placebo
干预措施: placebo (Drug)
androgel 5g
androgel 5g
干预措施: androgel (Drug)
androgel 10g
androgel 10g
干预措施: androgel 10g (Drug)
结局指标
主要结局
Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo
时间窗: 8 weeks
To measure the percent change from baseline at 8 weeks in Nuclear Factor kB DNA binding activity (in arbitrary units normalized to 100% at baseline) between AndroGel and Placebo using electrophoretic mobility shift assay (EMSA). Values at 8 weeks are converted to percent change and compared between the groups
次要结局
- Effect of Androgel Treatment on Reactive Oxygen Species Generation Compared to Placebo(8 weeks)
- Change in Inflammatory Mediator C-Reactive Protein (CRP) Following Treatment With Testosterone(8 week)
研究者
Paresh Dandona
MD
University at Buffalo