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Mental Stress & Diesel Exhaust on Cardiovascular Health (DESTRESS)

Primary Purpose

Blood Pressure, Inflammation, Catecholamines

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Trier social stress test

Diesel exhaust

About this trial

This is an interventional other trial for Blood Pressure

Eligibility Criteria

22 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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:

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

Sites / Locations

University of Washington Diesel Exhaust FacilityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Arm Label

Filtered Air

Diesel Exhaust

TSST/Stress only

Diesel Exhaust and stress

Arm Description

Subjects sit in a room for two hours breathing in filtered air which resembles levels of air pollution found in the ambient environment

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

Subjects undergo a mental stress test, known as the Trier Social Stress Test (TSST), which involves a public speaking and math task.

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.

Outcomes

Primary Outcome Measures

Change in norepinephrine

Urinary norepinephrine in ng/mg

Change in epinephrine

Urinary epinephrine in ng/mg

Change in dopamine

Urinary dopamine in ng/mg

Secondary Outcome Measures

Change in d-dimer

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

Change in fibrinogen

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

Change in interleukin-6 (IL-6)

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

Change in tumor necrosis factor alpha (TNF-a)

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

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

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

Full Information

NCT ID

NCT03467997

First Posted

December 12, 2017

Last Updated

November 1, 2018

Sponsor

University of Washington

Collaborators

National Institute of Environmental Health Sciences (NIEHS)

1. Study Identification

Unique Protocol Identification Number

NCT03467997

Brief Title

Mental Stress & Diesel Exhaust on Cardiovascular Health

Acronym

DESTRESS

Official Title

Effects of Mental Stress and Diesel Exhaust on Cardiovascular Health

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 22, 2018 (Actual)

Primary Completion Date

January 2020 (Anticipated)

Study Completion Date

January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

Collaborators

National Institute of Environmental Health Sciences (NIEHS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Blood Pressure, Inflammation, Catecholamines

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Filtered Air

Arm Type

No Intervention

Arm Description

Subjects sit in a room for two hours breathing in filtered air which resembles levels of air pollution found in the ambient environment

Arm Title

Diesel Exhaust

Arm Type

Active Comparator

Arm Description

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

Arm Title

TSST/Stress only

Arm Type

Active Comparator

Arm Description

Subjects undergo a mental stress test, known as the Trier Social Stress Test (TSST), which involves a public speaking and math task.

Arm Title

Diesel Exhaust and stress

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Trier social stress test

Other Intervention Name(s)

TSST

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Diesel exhaust

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in norepinephrine

Description

Urinary norepinephrine in ng/mg

Time Frame

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

Title

Change in epinephrine

Description

Urinary epinephrine in ng/mg

Time Frame

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

Title

Change in dopamine

Description

Urinary dopamine in ng/mg

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in d-dimer

Description

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

Title

Change in fibrinogen

Description

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

Time Frame

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

Title

Change in interleukin-6 (IL-6)

Description

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

Title

Change in tumor necrosis factor alpha (TNF-a)

Description

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

Title

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

Description

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 Pre-specified Outcome Measures:

Title

Change in blood pressure

Description

blood pressure in mm Hg

Time Frame

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

Title

Change in heart rate

Description

heart rate in beats per minute

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Karen Jansen, MS

Phone

206-685-6392

kjansen@uw.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anjum Hajat, PhD

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Washington Diesel Exhaust Facility

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karen Jansen, MS

Phone

206-685-6392

kjansen@uw.edu

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing 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.

Learn more about this trial

Mental Stress & Diesel Exhaust on Cardiovascular Health

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