Mental Stress & Diesel Exhaust on Cardiovascular Health

NCT03467997 | Unknown

• 2 other identifiers: STUDY00002051R00ES023498
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Inflammation; Catecholamines

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Change in d-dimer

  change in d-dimer from baseline (pre-exposure) to six hours post exposure

• Change in fibrinogen

  change in fibrinogen from baseline (pre-exposure) to six hours post exposure

• Change in interleukin-6 (IL-6)

  change in IL-6 from baseline (pre-exposure) to immediately after exposure

• Change in tumor necrosis factor alpha (TNF-a)

  change in TNF-a from baseline (pre-exposure) to immediately after exposure

• Change in interleukin-1b (IL-1b)

  change in IL-1b from baseline (pre-exposure) to immediately after exposure

Other Outcomes (2)

• Change in blood pressure

  Change in blood pressure from baseline (pre-exposure) to 22 hours post exposure

• Change in heart rate

  Change in blood pressure from baseline (pre-exposure) to 60 minutes post exposure

Study Arms (4)

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

Subjects sit in a room for two hours breathing in diesel exhaust at 200 micrograms of meter cubed.

Other: Diesel exhaust

TSST/Stress only

ACTIVE COMPARATOR

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

Diesel Exhaust and stress

ACTIVE COMPARATOR

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.

Behavioral: Trier social stress test; Other: Diesel exhaust

Interventions

Trier social stress test BEHAVIORAL

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.

Also known as: TSST

Diesel Exhaust and stress; TSST/Stress only

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).

Diesel Exhaust; Diesel Exhaust and stress

Eligibility Criteria

• Age: 22 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

University of Washington Diesel Exhaust Facility

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Inflammation

Interventions

Psychological Tests; Vehicle Emissions

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities; Complex Mixtures

Study Officials

• Anjum Hajat, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Jansen, MS

CONTACT

206-685-6392; kjansen@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: March 16, 2018
• Study Start: March 22, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: November 5, 2018

Record last verified: 2018-11

Locations

US (1)