Blood PressureDESTRESSNCT03467997
Mental Stress & Diesel Exhaust on Cardiovascular Health
A study testing Trier social stress test and Diesel exhaust in people with Blood Pressure and Inflammation, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Inflammation, Catecholamines
- What is being tested?
- Trier social stress test and Diesel exhaust
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2018to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington Diesel Exhaust Facility
Seattle, Washington, 98195
Karen Jansen, MS, 206-685-6392, kjansen@uw.edu
About this study
Official title: 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.
- Conditions
- Blood Pressure, Inflammation, Catecholamines
- Being tested
- Trier social stress test, Diesel exhaust
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trier social stress testBehavioural
Also called TSST
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.
Diesel exhaustOther
Diesel exhaust is an air pollutant found in the environment and produced by cars, trucks and other transportation modes (e.g. trains, planes).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Trier social stress test; Other: Diesel exhaust |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in norepinephrine
Urinary norepinephrine in ng/mg
Measured: Change in norepinephrine from baseline (pre-exposure) to immediately after exposure
Change in epinephrine
Urinary epinephrine in ng/mg
Measured: Change in epinephrine from baseline (pre-exposure) to immediately after exposure
Change in dopamine
Urinary dopamine in ng/mg
Measured: Change in dopamine from baseline (pre-exposure) to immediately after exposure
Secondary outcomes (5)
Change in d-dimer
plasma d-dimer (ug/ml) is a measure of coagulation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: change in IL-1b from baseline (pre-exposure) to immediately after exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start22 Mar 2018
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Principal investigator, Anjum Hajat, University of Washington
- Investigators
- Anjum Hajat, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467997
- Sponsor's protocol ID
- STUDY00002051
- Other IDs
- R00ES023498
- Acronym
- DESTRESS
- Status last verified
- Nov 2018
- First submitted
- 12 Dec 2017
- Last updated
- 5 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mental Stress and Diesel Exhaust on Cardiovascular Health
- ClinicalTrials.gov ID
- NCT03467997
- Acronym / sponsor ID
- DESTRESS / STUDY00002051
- Conditions
- Blood Pressure, Inflammation, Catecholamines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Diesel exhaustSubjects sit in a room for two hours breathing in diesel exhaust at 200 micrograms of meter cubed. |
| TSST/Stress only | Active comparator | Behavioral: Trier social stress testSubjects undergo a mental stress test, known as the Trier Social Stress Test (TSST), which involves a public speaking and math task. |
| Diesel Exhaust and stress | Active comparator | Behavioral: Trier social stress test, Other: Diesel exhaustSubjects 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. |
Who may qualify
- Ages
- 22 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trier social stress testAlso: TSSTSubjects are asked to give a 5 minute speech on a topic selected by the investigator. Then they are asked to subtract 7 from 758. | Behavioural | Diesel Exhaust and stress, TSST/Stress only |
| Diesel exhaustDiesel exhaust is an air pollutant found in the environment and produced by cars, trucks and other transportation modes (e.g. trains, planes). | Other | Diesel Exhaust, Diesel Exhaust and stress |
Primary outcome
Change in norepinephrine
Time frame: Change in norepinephrine from baseline (pre-exposure) to immediately after exposure
Urinary norepinephrine in ng/mg
Change in epinephrine
Time frame: Change in epinephrine from baseline (pre-exposure) to immediately after exposure
Urinary epinephrine in ng/mg
Change in dopamine
Time frame: Change in dopamine from baseline (pre-exposure) to immediately after exposure
Urinary dopamine in ng/mg
5 secondary outcomes
Change in d-dimer
Time frame: change in d-dimer from baseline (pre-exposure) to six hours post exposure
Change in fibrinogen
Time frame: change in fibrinogen from baseline (pre-exposure) to six hours post exposure
Change in interleukin-6 (IL-6)
Time frame: change in IL-6 from baseline (pre-exposure) to immediately after exposure
Change in tumor necrosis factor alpha (TNF-a)
Time frame: change in TNF-a from baseline (pre-exposure) to immediately after exposure
Change in interleukin-1b (IL-1b)
Time frame: change in IL-1b from baseline (pre-exposure) to immediately after exposure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anjum Hajat, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trier social stress test and Diesel exhaust in people with Blood Pressure and Inflammation, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen Jansen, MS (206-685-6392, kjansen@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in norepinephrine (time frame: Change in norepinephrine from baseline (pre-exposure) to immediately after exposure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.