ClinicalTrials.gg
Status unknownNCT03467997DESTRESSUpdated Nov 5, 2018

Mental Stress & Diesel Exhaust on Cardiovascular Health

An interventional study of Trier social stress test and Diesel exhaust in Blood Pressure, Inflammation and Catecholamines, sponsored by University of Washington. Status unknown at 1 site in United States. Open to participants aged 22 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-05.

Sponsored by University of Washington · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
22 Years to 49 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Blood Pressure
  • Inflammation
  • Catecholamines

Browse trials for

03

In context

Inflammation

3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.

This study's planned enrollment of 22 is below the median of 50 across 2,577 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 (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 during the study
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
22 participants (estimated)

Study arms

  • 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

  • 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

  • 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.

    Behavioral: Trier social stress test · Other: Diesel exhaust

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.

    Also known as: TSST

  • 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).

06

What researchers measure

Primary outcomes

  1. Change in norepinephrine

    Urinary norepinephrine in ng/mg

    Time frame: Change in norepinephrine from baseline (pre-exposure) to immediately after exposure

  2. Change in epinephrine

    Urinary epinephrine in ng/mg

    Time frame: Change in epinephrine from baseline (pre-exposure) to immediately after exposure

  3. Change in dopamine

    Urinary dopamine in ng/mg

    Time frame: Change in dopamine from baseline (pre-exposure) to immediately after exposure

Secondary outcomes

  1. Change in d-dimer

    plasma d-dimer (ug/ml) is a measure of coagulation

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

  2. Change in fibrinogen

    plasma fibrinogen (mg/dl) is a measure of coagulation

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

  3. Change in interleukin-6 (IL-6)

    plasma IL-6, measured in pg/ml, is a marker of inflammation

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

  4. Change in tumor necrosis factor alpha (TNF-a)

    plasma TNF-a, measured in pg/ml, is a marker of inflammation

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

  5. Change in interleukin-1b (IL-1b)

    plasma IL-1b, measured in pg/ml, is a marker of inflammation

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

Other outcomes

  1. Change in blood pressure

    blood pressure in mm Hg

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

  2. Change in heart rate

    heart rate in beats per minute

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

07

Study locations

1 of 1 sites recruiting
  • University of Washington Diesel Exhaust Facility
    Seattle, Washington 98195, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03467997
Responsible party
Anjum Hajat (Assistant Professor, University of Washington) — Principal investigator
First posted
Mar 16, 2018
Start date
Mar 22, 2018
Primary completion
Jan 2020 (estimated)
Completion
Jan 2020 (estimated)
Last update
Nov 5, 2018

Study contacts

Karen Jansen, MS
Contact
kjansen@uw.edu
206-685-6392
Anjum Hajat, PhD
principal investigator · University of Washington

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion