Blood Pressure, Inflammation, Catecholamines
Conditions
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.
Interventions
BEHAVIORALTrier social stress test
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.
OTHERDiesel exhaust
Diesel exhaust is an air pollutant found in the environment and produced by cars, trucks and other transportation modes (e.g. trains, planes).
Sponsors
National Institute of Environmental Health Sciences (NIEHS)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change in norepinephrine | Change in norepinephrine from baseline (pre-exposure) to immediately after exposure | Urinary norepinephrine in ng/mg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactKaren Jansen, MS
Outcome results
None listed