Phase 4 Study That Evaluates the Presence of Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Subjects With Hypogonadotrophic Hypogonadism and Effects of Two Different Testosterone Replacement Regiments on These Parameters.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- The alterations in the measures for endothelial functions
研究概览
简要总结
The study searched for answers to two questions
- Is there endothelial dysfunction, inflammation and insulin resistance in patients with congenital hypogonadotropic hypogonadism?
- What is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Treatment naive
- •Hypogonadotrophic hypogonadism
排除标准
- •Previous history of androgen replacement
- •Chronic metabolic disorders
研究组 & 干预措施
Injectable Testosterone esters
Testosteron 250mg injection per 3-4 weeks for 6 months
干预措施: Testosterone 250mg injection (Drug)
Daily testosterone transdermal gel
干预措施: Testosteron 50 mg transdermal gel (Drug)
结局指标
主要结局
The alterations in the measures for endothelial functions
时间窗: 6 months
The alterations in Endothelial functions are determined by measuring plasma asymmetric dimethylarginine (ADMA) levels, as a surrogate. ADMA measurement is performed by ELISA kit (Immunodiagnostic, Bernheim, Germany)(Catalog Number 7828) with a minimal detection limit of 0.05µmol/L.
The alterations in the measures of insulin resistance
时间窗: 6 months.
The alterations in insulin sensitivity are estimated by using the homeostasis model assessment (HOMA) index by the formula, HOMA = (insulin x glucose)/405.
The alterations in the measures of inflammation
时间窗: 6 months
The alterations in the measures of inflammation are determined by measuring plasma TWEAK levels. ELISA kit (Bender MedSystems, Lot Nr.BMS2006INST, Vienna, Austria) was used.
次要结局
未报告次要终点
研究者
Alper Sonmez
Associate Professor in Medicine
Gulhane School of Medicine