Clinical trial NCT03467997: Mental Stress & Diesel Exhaust on Cardiovascular Health
Official title: Effects of Mental Stress and Diesel Exhaust on Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Pressure
Inflammation
Catecholamines
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2018-03-16
Enrollment: 22
Sex: ALL
Minimum age (years): 22
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

1. Smoking: We rule out active smoking by checking urine cotinine during our study.
2. History of high blood pressure: We objectively measure BP during in-person screening and exclude those with blood pressure (\>130/85 mmHg).
3. Asthmatic: Spirometry is done at screening to rule out asthma.
4. Diabetic: We obtain fasting blood sugar to rule out diabetes at screening (\>125 mg/dL)
5. Cholesterol: We obtain fasting blood lipid levels to rule out hypercholesterolemia at screening (\>200 mg/dL).
6. History of PTSD: Subjects will be asked about prior PTSD diagnosis during the phone and in person screen.
7. Any other chronic condition requiring ongoing care based on medication use.
8. A body mass index (weight in kilograms divided by height in meters squared) greater than 26 and less than 18.5
9. A female of childbearing age with a positive pregnancy test
10. A female of childbearing age who is unwilling to use effective contraception during the study

Primary outcomes:
measure: Change in norepinephrine
timeFrame: Change in norepinephrine from baseline (pre-exposure) to immediately after exposure
measure: Change in epinephrine
timeFrame: Change in epinephrine from baseline (pre-exposure) to immediately after exposure
measure: Change in dopamine
timeFrame: Change in dopamine from baseline (pre-exposure) to immediately after exposure
Secondary outcomes:
measure: Change in d-dimer
timeFrame: change in d-dimer from baseline (pre-exposure) to six hours post exposure
measure: Change in fibrinogen
timeFrame: change in fibrinogen from baseline (pre-exposure) to six hours post exposure
measure: Change in interleukin-6 (IL-6)
timeFrame: change in IL-6 from baseline (pre-exposure) to immediately after exposure
measure: Change in tumor necrosis factor alpha (TNF-a)
timeFrame: change in TNF-a from baseline (pre-exposure) to immediately after exposure
measure: Change in interleukin-1b (IL-1b)
timeFrame: change in IL-1b from baseline (pre-exposure) to immediately after exposure
Other outcomes:
measure: Change in blood pressure
timeFrame: Change in blood pressure from baseline (pre-exposure) to 22 hours post exposure
measure: Change in heart rate
timeFrame: Change in blood pressure from baseline (pre-exposure) to 60 minutes post exposure
Locations:
city: Seattle
country: United States
facility: University of Washington Diesel Exhaust Facility
state: Washington
Study officials:
affiliation: University of Washington
name: Anjum Hajat, PhD
role: PRINCIPAL_INVESTIGATOR
References: