Mental Stress & Diesel Exhaust on Cardiovascular Health (DESTRESS)

Effects of Mental Stress and Diesel Exhaust on Cardiovascular Health

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.

Study Overview

• Status: Unknown
• Conditions: Inflammation; Blood Pressure; Catecholamines
• Intervention / Treatment: Other: Diesel exhaust; Behavioral: Trier social stress test

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen Jansen, MS; Phone Number: 206-685-6392; Email: kjansen@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington Diesel Exhaust Facility
      • Contact: Karen Jansen, MS; Phone Number: 206-685-6392; Email: kjansen@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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
Active Comparator: Diesel Exhaust; Subjects sit in a room for two hours breathing in diesel exhaust at 200 micrograms of meter cubed.	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).
Active Comparator: 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.	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 Names: TSST
Active Comparator: 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.	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).; 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 Names: TSST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in norepinephrine	Urinary norepinephrine in ng/mg	Change in norepinephrine from baseline (pre-exposure) to immediately after exposure
Change in epinephrine	Urinary epinephrine in ng/mg	Change in epinephrine from baseline (pre-exposure) to immediately after exposure
Change in dopamine	Urinary dopamine in ng/mg	Change in dopamine from baseline (pre-exposure) to immediately after exposure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in fibrinogen	plasma fibrinogen (mg/dl) is a measure of coagulation	change in fibrinogen from baseline (pre-exposure) to six hours post exposure
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	blood pressure in mm Hg	Change in blood pressure from baseline (pre-exposure) to 22 hours post exposure
Change in heart rate	heart rate in beats per minute	Change in blood pressure from baseline (pre-exposure) to 60 minutes post exposure

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: Anjum Hajat, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2018
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: March 10, 2018
• First Posted (Actual): March 16, 2018

Study Record Updates

• Last Update Posted (Actual): November 5, 2018
• Last Update Submitted That Met QC Criteria: November 1, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Inflammation; Stress, Psychological
• Other Study ID Numbers: STUDY00002051; R00ES023498 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We may share some of the clinical data collected such as blood pressure, spirometry and other markers of cardiac function with researchers interested in addressing related study questions. Direct identifiers will not be stored or shared, but rather only de-identified bio-specimens and data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No