Mental Stress & Diesel Exhaust on Cardiovascular Health

Inflammation Clinical Trial

— DESTRESS  

Official title:

Effects of Mental Stress and Diesel Exhaust on Cardiovascular Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03467997
• Other study ID #: STUDY00002051
• Secondary ID: R00ES023498
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2018
• Est. completion date: January 2020

Study information

• Verified date: November 2018
• Source: University of Washington
• Contact: Karen Jansen, MS
• Phone: 206-685-6392
• Email: kjansen[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Catecholamines
• Inflammation
• Stress, Psychological

Intervention

Behavioral:
• Trier 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.

Other:
• Diesel exhaust
Diesel exhaust is an air pollutant found in the environment and produced by cars, trucks and other transportation modes (e.g. trains, planes).

Locations

Country	Name	City	State
United States	University of Washington Diesel Exhaust Facility	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in blood pressure	blood pressure in mm Hg	Change in blood pressure from baseline (pre-exposure) to 22 hours post exposure
Other	Change in heart rate	heart rate in beats per minute	Change in blood pressure from baseline (pre-exposure) to 60 minutes post exposure
Primary	Change in norepinephrine	Urinary norepinephrine in ng/mg	Change in norepinephrine from baseline (pre-exposure) to immediately after exposure
Primary	Change in epinephrine	Urinary epinephrine in ng/mg	Change in epinephrine from baseline (pre-exposure) to immediately after exposure
Primary	Change in dopamine	Urinary dopamine in ng/mg	Change in dopamine from baseline (pre-exposure) to immediately after exposure
Secondary	Change in d-dimer	plasma d-dimer (ug/ml) is a measure of coagulation	change in d-dimer from baseline (pre-exposure) to six hours post exposure
Secondary	Change in fibrinogen	plasma fibrinogen (mg/dl) is a measure of coagulation	change in fibrinogen from baseline (pre-exposure) to six hours post exposure
Secondary	Change in interleukin-6 (IL-6)	plasma IL-6, measured in pg/ml, is a marker of inflammation	change in IL-6 from baseline (pre-exposure) to immediately after exposure
Secondary	Change in tumor necrosis factor alpha (TNF-a)	plasma TNF-a, measured in pg/ml, is a marker of inflammation	change in TNF-a from baseline (pre-exposure) to immediately after exposure
Secondary	Change in interleukin-1b (IL-1b)	plasma IL-1b, measured in pg/ml, is a marker of inflammation	change in IL-1b from baseline (pre-exposure) to immediately after exposure