Effects of Mental Stress and Diesel Exhaust on Cardiovascular Health
试验速览
- 阶段
- 不适用
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in norepinephrine
研究概览
简要总结
This study uses an experimental design to conduct a double-blind, randomized, crossover study where participants receive both diesel exhaust and a mental stress test in a controlled setting. My hypothesis is that the synergistic effect of stress and air pollution will result in higher levels of stress and inflammation (measured via biological markers) as well as poorer cardiovascular disease related outcomes compared to the independent effect of each exposure separately.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smokers without history of high blood pressure, asthma, diabetes, high cholesterol, post-traumatic stress disorder (PTSD) or any other chronic condition that requires ongoing care.
排除标准
- •Smoking: We rule out active smoking by checking urine cotinine during our study.
- •History of high blood pressure: We objectively measure BP during in-person screening and exclude those with blood pressure (>130/85 mmHg).
- •Asthmatic: Spirometry is done at screening to rule out asthma.
- •Diabetic: We obtain fasting blood sugar to rule out diabetes at screening (>125 mg/dL)
- •Cholesterol: We obtain fasting blood lipid levels to rule out hypercholesterolemia at screening (>200 mg/dL).
- •History of PTSD: Subjects will be asked about prior PTSD diagnosis during the phone and in person screen.
- •Any other chronic condition requiring ongoing care based on medication use.
- •A body mass index (weight in kilograms divided by height in meters squared) greater than 26 and less than 18.5
- •A female of childbearing age with a positive pregnancy test
- •A female of childbearing age who is unwilling to use effective contraception during the study
研究组 & 干预措施
Filtered Air
Subjects sit in a room for two hours breathing in filtered air which resembles levels of air pollution found in the ambient environment
Diesel Exhaust
Subjects sit in a room for two hours breathing in diesel exhaust at 200 micrograms of meter cubed.
干预措施: Diesel exhaust (Other)
TSST/Stress only
Subjects undergo a mental stress test, known as the Trier Social Stress Test (TSST), which involves a public speaking and math task.
干预措施: Trier social stress test (Behavioral)
Diesel Exhaust and stress
Subjects sit in a room for two hours breathing in diesel exhaust at 200 micrograms of meter cubed and are subject to a mental stress test (TSST) which involves a public speaking and math task.
干预措施: Trier social stress test (Behavioral)
Diesel Exhaust and stress
Subjects sit in a room for two hours breathing in diesel exhaust at 200 micrograms of meter cubed and are subject to a mental stress test (TSST) which involves a public speaking and math task.
干预措施: Diesel exhaust (Other)
结局指标
主要结局
Change in norepinephrine
时间窗: Change in norepinephrine from baseline (pre-exposure) to immediately after exposure
Urinary norepinephrine in ng/mg
Change in epinephrine
时间窗: Change in epinephrine from baseline (pre-exposure) to immediately after exposure
Urinary epinephrine in ng/mg
Change in dopamine
时间窗: Change in dopamine from baseline (pre-exposure) to immediately after exposure
Urinary dopamine in ng/mg
次要结局
- Change in d-dimer(change in d-dimer from baseline (pre-exposure) to six hours post exposure)
- Change in fibrinogen(change in fibrinogen from baseline (pre-exposure) to six hours post exposure)
- Change in interleukin-6 (IL-6)(change in IL-6 from baseline (pre-exposure) to immediately after exposure)
- Change in interleukin-1b (IL-1b)(change in IL-1b from baseline (pre-exposure) to immediately after exposure)
- Change in tumor necrosis factor alpha (TNF-a)(change in TNF-a from baseline (pre-exposure) to immediately after exposure)
研究者
Anjum Hajat
Assistant Professor
University of Washington