Mental Stress & Diesel Exhaust on Cardiovascular Health

NCT03467997 — Not applicable, Unknown, 22 participants, University of Washington

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Effects of Mental Stress and Diesel Exhaust on Cardiovascular Health

Registry	NCT03467997, acronym DESTRESS
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: triple, other
Enrollment	22 (Estimated)
Sponsor	University of Washington (Other); collaborators: National Institute of Environmental Health Sciences (NIEHS)
Conditions	Blood Pressure, Inflammation, Catecholamines
Interventions	Trier social stress test, Diesel exhaust (Behavioral, other)
Dates	start 2018-03-22, primary completion 2020-01-01 (estimated), completion 2020-01-01 (estimated), first posted 2018-03-16, last updated 2018-11-05
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Filtered Air	No intervention		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	Active comparator	Other: Diesel exhaust	Subjects sit in a room for two hours breathing in diesel exhaust at 200 micrograms of meter cubed.
TSST/Stress only	Active comparator	Behavioral: Trier social stress test	Subjects undergo a mental stress test, known as the Trier Social Stress Test (TSST), which involves a public speaking and math task.
Diesel Exhaust and stress	Active comparator	Behavioral: Trier social stress test; Other: Diesel exhaust	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.

Trier social stress test (Behavioral), also known as TSST: Subjects are asked to give a 5 minute speech on a topic selected by the investigator. Then they are asked to subtract 7 from 758.
Diesel exhaust (Other): Diesel exhaust is an air pollutant found in the environment and produced by cars, trucks and other transportation modes (e.g. trains, planes).

+Outcome measures

Primary outcomes

Change in norepinephrine [Change in norepinephrine from baseline (pre-exposure) to immediately after exposure]: Urinary norepinephrine in ng/mg
Change in epinephrine [Change in epinephrine from baseline (pre-exposure) to immediately after exposure]: Urinary epinephrine in ng/mg
Change in dopamine [Change in dopamine from baseline (pre-exposure) to immediately after exposure]: Urinary dopamine in ng/mg

Secondary outcomes

Change in d-dimer [change in d-dimer from baseline (pre-exposure) to six hours post exposure]: plasma d-dimer (ug/ml) is a measure of coagulation
Change in fibrinogen [change in fibrinogen from baseline (pre-exposure) to six hours post exposure]: plasma fibrinogen (mg/dl) is a measure of coagulation
Change in interleukin-6 (IL-6) [change in IL-6 from baseline (pre-exposure) to immediately after exposure]: plasma IL-6, measured in pg/ml, is a marker of inflammation
Change in tumor necrosis factor alpha (TNF-a) [change in TNF-a from baseline (pre-exposure) to immediately after exposure]: plasma TNF-a, measured in pg/ml, is a marker of inflammation
Change in interleukin-1b (IL-1b) [change in IL-1b from baseline (pre-exposure) to immediately after exposure]: plasma IL-1b, measured in pg/ml, is a marker of inflammation

Other outcomes

Change in blood pressure [Change in blood pressure from baseline (pre-exposure) to 22 hours post exposure]: blood pressure in mm Hg
Change in heart rate [Change in blood pressure from baseline (pre-exposure) to 60 minutes post exposure]: heart rate in beats per minute

+Eligibility

Sex: All, ages: 22 Years to 49 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
University of Washington Diesel Exhaust Facility	Seattle, Washington	United States	Recruiting

+Investigators

Anjum Hajat, PhD, Principal investigator, University of Washington

+Funding

NIH grants: R00ES023498