Effect of Free Fatty Acids on Androgen Precursors in Vivo in Healthy Young Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- change of DHEAS
研究概览
简要总结
The purpose of this study is to determine whether free fatty acids modify the androgen levels in healthy young women.
详细描述
Free fatty acids (FFA) are known to play an important role by inducing insulin resistance and metabolic disturbances in obesity and type 2 diabetes. In addition, FFAs seems to have a stimulatory effect on adrenal androgen precursors in men. However, the effect of FFAs on androgen precursors and androgens in women is yet unknown.
Therefore the effect of increased FFAs on adrenal androgens and androgen precursors should be investigated in a randomized controlled cross-over trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy men and women
排除标准
- •diabetes mellitus or impaired glucose tolerance
- •clinical signs of hyperandrogenism
- •polycystic ovary
- •hormonal therapy
- •BMI > 30 kg/m2
- •dysmenorrhoea
研究组 & 干预措施
LHI
to perform an i.v. lipid heparin infusion for 4 h
干预措施: lipid/heparin infusion (Drug)
SHI
to perform an i.v. saline heparin infusion for 4 h
干预措施: lipid/heparin infusion (Drug)
结局指标
主要结局
change of DHEAS
时间窗: 1 day
Measurement of serum DHEAS
change of testosterone
时间窗: 1 day
Measurement of serum testosterone
change of androstenedione
时间窗: 1 day
Measurement of serum androstenedione
change of DHEA
时间窗: 1 day
Measurement of serum DHEA
次要结局
- urinary androgen excretion(1 day)
- urinary cortisol excretion(1 day)
- changes in metabolic parameters (e.g. FGF-21)(1 day)
- urinary cortisone excretion(1 day)
研究者
Professor Joachim Spranger
professor
Charite University, Berlin, Germany