D-chiroinositol Administration for Testosterone Level Improvement in Hypogonadal Males
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change from Baseline Serum Testosterone at 1 month
研究概览
简要总结
D-chiroinositol (DCI), is known as second messenger of insulin pathway, but recently several works have reported the influence of DCI on steroidogenesis. In particular, the DCI capabilities to regulate aromatase expression and testosterone biosynthesis are arising. In this regard, DCI administration in case of reduced levels of testosterone, could be a good therapeutic opportunity. For this reason, the treatment of Late-Onset Male Hypogonadism (LOH) in undoubtedly an interesting target. LOH is a reduction of testosterone level due to advancing age, currently treated with Testosterone Replacement Therapy (TRT). Unfortunately, there is a lack of information about TRT safety, especially in older men. For these reasons, the aim of this study is to evaluate the effect of DCI treatment on testosterone accumulation in LOH patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men, with a diagnosis of Late-Onset Male Hypogonadism
- •Insulin resistance (HOMA Index > 2,5)
- •BMI between 25 and 30
排除标准
- •Alcohol intake and/or drug abuse
- •Recent hormonal treatment
- •Systemic or endocrine diseases
- •Male accessory gland infection
- •Clinical history of cryptorchidism or varicocele and micro-orchidism
研究组 & 干预措施
D-chiroinositol treatment
干预措施: D-chiroinositol (Dietary Supplement)
结局指标
主要结局
Change from Baseline Serum Testosterone at 1 month
时间窗: At baseline and after 30 days of treatment
Level of testosterone detected in the blood in ng/dL
次要结局
- Change from Baseline Glycaemia at 1 month(At baseline and after 30 days of treatment)
- Change from Baseline Oestradiol at 1 month(At baseline and after 30 days of treatment)
- Change from Baseline HOMA index at 1 month(At baseline and after 30 days of treatment)
- Change from Baseline Luteinizing Hormone at 1 month(At baseline and after 30 days of treatment)
- Change from Baseline BMI at 1 month(At baseline and after 30 days of treatment)
- Change from Baseline Insulin at 1 month(At baseline and after 30 days of treatment)
- Change from Baseline Waist circumference at 1 month(At baseline and after 30 days of treatment)
- Change from Baseline Weight at 1 month(At baseline and after 30 days of treatment)
- Change from Baseline Androstenedione at 1 month(At baseline and after 30 days of treatment)
- Change from Baseline Oestrone at 1 month(At baseline and after 30 days of treatment)
- Change from Baseline Testosterone/Oestradiol ratio at 1 month(At baseline and after 30 days of treatment)
- Change from Baseline Strength Test at 1 month(At baseline and after 30 days of treatment)