Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Free Plasma Testosterone Levels
研究概览
简要总结
Women with androgen excess polycystic ovary syndrome (AE-PCOS) leads to hypertension.
详细描述
Our scientific premise is that in AE-PCOS women, the androgen-dominant hormonal milieu causes BP increases via sympathetic activation, vasoconstriction and renal sympathetic nervous system activation. Moreover, this androgen-dominant milieu increases BP via activation of the renin-angiotensin system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Clinical Diagnosis of Polycystic Ovary Syndrome
- •Able to inject study drug
- •Able to swallow pills
- •Diagnosis of Insulin resistance
排除标准
- •Any woman that does not fit the inclusion criteria
研究组 & 干预措施
Healthy Control
Healthy control participants.
干预措施: GnRH antagonist (Drug)
Healthy Control
Healthy control participants.
干预措施: GnRH antagonist + MethylTESTOSTERone 5 MG (Drug)
AE-PCOS
Participants with AE-PCOS.
干预措施: GnRH antagonist (Drug)
AE-PCOS
Participants with AE-PCOS.
干预措施: GnRH antagonist + MethylTESTOSTERone 5 MG (Drug)
结局指标
主要结局
Free Plasma Testosterone Levels
时间窗: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Concentration of testosterone in blood.
Baroreflex Response to LBNP
时间窗: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
forearm blood flow (ultrasound)/mean arterial pressure as a linear function of lower body negative pressure. This is an important measure of autonomic control of blood pressure. Indicating the the sensitivity of changes in vessel diameter in response to blood pooling (induced by lower body negative pressure).
Renal Response to LBNP
时间窗: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
POST Lower body negative pressure Plasma renin activity
Resting Systolic Blood Pressure
时间窗: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Blood pressure prior to lower body negative pressure
Renal Responses to LBNP
时间窗: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
PRE lower body negative pressure Plasma renin activity
Final Systolic Blood Pressure
时间窗: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
SBP at the end of lower body negative pressure
Sympathetic Baroreflex
时间窗: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
microneurography, diastolic blood pressure (finipres) This is an important measure of autonomic control of blood pressure. Indicating the the sensitivity of changes in muscle sympathetic nerve activity in response to small changes in blood pressure induced by drug perfusion (modified Oxford).
Resting Sympathetic Activity
时间窗: Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone
Total sympathetic nerve activity
次要结局
- Aldosterone(Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone)
- Renal Responses(Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone)