Salivary Testosterone in Men: Diurnal Variation and Post-prandial Responses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in salivary testosterone during the day independent of prandial state
研究概览
简要总结
The purpose is to evaluate Sal-T against standard biomarkers of male gonadal status based on serum T, calculated free T and BAT. The optimal salivary sampling in terms of fasting and time of day will also be defined.
The ultimate aim is to add Sal-T into the Trust's repertoire of tests in investigating suspected hypogonadism in men.
详细描述
To investigate whether salivary (free) testosterone is subject to similar prandial variations reported for serum total testosterone.
Study 1:
Assessment of diurnal variation in salivary testosterone adjusted for prandial state in 20 healthy men.
Study 2:
Measurement of salivary and serum testosterone and related biomarkers before and after a standard 75g oral glucose load in 40 men.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Aged 20-60 years
排除标准
- •Subjects with learning disability or those lacking mental capacity to give consent.
- •On (prescribed and over-the-counter) medication and herbal remedies known to affect androgen metabolism.
- •Known hypogonadism.
- •Conditions known to affect androgen metabolism, including chronic inflammatory diseases, chronic liver disease, chronic kidney disease and thyroid dysfunction.
- •Any co-morbidity.
- •Periodontal disease.
- •Dental work 48 hours prior to the test.
- •Exercise on the day, prior to and during sampling periods.
- •Brushed teeth within 1hr prior to sample collection.
- •Obesity defined as a body mass index (BMI) of greater than 29.9 kg/m2As
- •2nd part of study for glucose load - oral glucose tolerance test (OGTT):
- •Inclusion criteria:
- •Aged over 40-60 years.
- •Attending for routine 75 g OGTT
- •Exclusion criteria:
- •Subjects with learning disability or lacking mental capacity to give consent.
- •On (prescribed and over-the-counter) medication and herbal remedies known to affect androgen metabolism.
- •Known hypogonadism.
- •Conditions known to affect androgen metabolism, including chronic inflammatory diseases, chronic liver disease, chronic kidney disease and thyroid dysfunction.
- •Subjects with difficult venous access.
- •Periodontal disease.
- •Dental work 48 hours prior to the test.
- •Brushed teeth within 1hour prior to sample collection.
- •Exercise on day prior to and during the OGTT.
结局指标
主要结局
Changes in salivary testosterone during the day independent of prandial state
时间窗: 24 hours
testosterone levels
Changes in salivary testosterone following an oral glucose load
时间窗: 2 hours
testosterone levels
次要结局
未报告次要终点