Endothelin Receptor Function and Acute Stress (End-Stress)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Flow-Mediated Dilation (FMD)
研究概览
简要总结
Our bodies respond differently to stress. Animal studies by the investigators have found that endothelin-1 plays a role in regulating blood pressure in response to stress. This study is an extension of the investigators previous animal work to evaluate the role of endothelin-1 during stress in humans.
详细描述
Using a salt sensitive animal model of prehypertension, the Dahl S rat,the investigators have previously published that acute stress elicits a pressor response that is accompanied by an increase in 8 isoprostane and endothelin-1. However, the pressor response is suppressed by endothelin A/B receptor antagonism. Moreover, the investigators have identified that the increase in 8-isoprostane occurs downstream of endothelin receptor activation. These data indicate that endothelin receptor activation is a main player In the pressor response to acute stress in pre-hypertensive animals; however, this phenomenon has yet to be elucidated in humans.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and premenopausal women (Ages 18-50 years old)
- •Self-reported Black and White adults
- •Lean adults (BMl <25 kg/m^)
- •Obese adults (BMl > 30 kg/m^)
排除标准
- •Having a BMI less than 16 kg/m2 (severely and very severely underweight) or that is greater than 40 kg/m2 (Class III obesity)
- •Having evidence of cardiovascular, pulmonary, renal, hepatic, cerebral, or metabolic disease
- •Having evidence of pregnancy
- •Using medications that affect vascular tone (i.e., nitrates, etc.)
- •Postmenopausal women
- •Uncontrolled hypertension
- •Individuals who are on a restricted salt diet
- •Having a history of chronic pain
- •Having a history of rheumatoid arthritis
- •Using medications that are contraindicated with bosentan (i.e. glyburide, cyclosporine)
- •Liver dysfunction (which may be identified with the blood sample we take)
研究组 & 干预措施
Bosentan
Sub-Chronic (3 days) Bosentan 250mg/day.
干预措施: Bosentan (Drug)
Placebo
Stress response and endothelial function will be determined following a three day treatment of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Flow-Mediated Dilation (FMD)
时间窗: Baseline and 3 days
Brachial artery FMD induced by reactive hyperemia will be used to assess vascular endothelial function.
次要结局
- Arterial Stiffness Evaluation (PWV)(Baseline and 3 days)
- Physio Flow(Baseline and 3 days)
- Femoral blood flow(Baseline and 3 days)
- Blood Pressure(Baseline and 3 days)
- Resting Energy Expenditure(Baseline and 3 days)
研究者
Ryan Harris
Assistant Professor
Augusta University