HealthyNCT01548625
Cardiovascular Effects of Incremental Diesel Exhaust Inhalation in Middle-Aged Healthy GSTM1 Null Human Volunteers
An observational study of Healthy, run by Environmental Protection Agency (EPA) at 1 site in United States.
Trial summary
Purpose: A growing body of epidemiological data suggests an increased risk of cardiovascular events associated with air pollutants. Reactive oxygen species (ROS) have been implicated as a potential mechanism for the adverse effects of air pollutants and genetic polymorphisms of the glutathione-s-transferases (GSTs)… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Nov 2008
- Phase
- Observational
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy 50-75 year-old male and female subjects with GSTM1 null genotype.
Who may be able to join
- Age 50-75 years old generally healthy male and female.
- Normal resting ECG.
- Oxygen saturation greater than 94% at the time of physical exam.
Who cannot join
- A history of angina, cardiac arrhythmias, and ischemic myocardial infarction or coronary bypass surgery.
- Cardiac pacemaker.
- Uncontrolled hypertension (> 150 systolic, > 90 diastolic).
- Neurodegenerative diseases such as Parkinson's and Alzheimer disease.
- A history of chronic illnesses such as diabetes, cancer, rheumatologic diseases, immunodeficiency state, known cardiovascular disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or severe asthma.
- History of bleeding diathesis.
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- Currently taking HMG-CoA reductase inhibitors for hyperlipidemia including lovastatin, pravastatin, simvastatin, and atorvastatin.
- Currently taking beta-blockers to control hypertension and/or arrhythmias.
- Use of oral anticoagulants.
- Participants must refrain from all over-the-counter NSAIDs for a period of two weeks prior to exposure. Low-dose aspirin will be acceptable. Medications not specifically mentioned here may be reviewed by the investigators prior to a participant's inclusion in the study.
- Subjects who are currently smoking or have smoking history within 1 year of study (defined as more than one pack of cigarettes in the past year).
- Subject is pregnant, attempting to become pregnant or breastfeeding.
- No exposure will be conducted within 4 weeks of a respiratory tract infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
EPA Human Studies Facility
Chapel Hill, North Carolina, 27599
About this study
Purpose: A growing body of epidemiological data suggests an increased risk of cardiovascular events associated with air pollutants. Reactive oxygen species (ROS) have been implicated as a potential mechanism for the adverse effects of air pollutants and genetic polymorphisms of the glutathione-s-transferases (GSTs) have been shown to participate in the antioxidant defenses to air pollutants. This study examined the dose effects of diesel exhaust exposure on the cardiovascular system in healthy middle-aged subjects.
Participants: Six healthy 50-75 year-old male and female subjects with GSTM1 null genotype had 3 sequential exposures to the diesel exhausts at concentrations approximately 100 µg/m3, 200 µg/m3, and 300 µg/m3 for 2 hours with a about 2 weeks of interval between exposures.
- Conditions
- Healthy
- Keywords
- risk of cardiovascular events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy middle-aged human volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular effects of DE exposure
Brachial artery ultrasound was performed to measure vascular effects of DE exposure
Measured: One hour before and 1 hour after DE exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startJul 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Environmental Protection Agency (EPA)
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Haiyan Tong, Environmental Protection Agency (EPA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548625
- Sponsor's protocol ID
- DE pilot
- Status last verified
- Mar 2012
- First submitted
- 5 Mar 2012
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Effects of Incremental Diesel Exhaust Inhalation in Middle-Aged Healthy GSTM1 Null Human Volunteers
- ClinicalTrials.gov ID
- NCT01548625
- Acronym / sponsor ID
- DE pilot
- Conditions
- Healthy
- Keywords
- risk of cardiovascular events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Environmental Protection Agency (EPA)US federal agency
- Study start
- Jul 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 8 Mar 2012 (estimated)
- 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.
Purpose: A growing body of epidemiological data suggests an increased risk of cardiovascular events associated with air pollutants. Reactive oxygen species (ROS) have been implicated as a potential mechanism for the adverse effects of air pollutants and genetic polymorphisms of the glutathione-s-transferases (GSTs) have been shown to participate in the antioxidant defenses to air pollutants. This study examined the dose effects of diesel exhaust exposure on the cardiovascular system in healthy middle-aged subjects.
Participants: Six healthy 50-75 year-old male and female subjects with GSTM1 null genotype had 3 sequential exposures to the diesel exhausts at concentrations approximately 100 µg/m3, 200 µg/m3, and 300 µg/m3 for 2 hours with a about 2 weeks of interval between exposures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy middle-aged human volunteers | – | – |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy 50-75 year-old male and female subjects with GSTM1 null genotype.
Key inclusion criteria (3 listed)
- Age 50-75 years old generally healthy male and female.
- Normal resting ECG.
- Oxygen saturation greater than 94% at the time of physical exam.
Key exclusion criteria (13 listed)
- A history of angina, cardiac arrhythmias, and ischemic myocardial infarction or coronary bypass surgery.
- Cardiac pacemaker.
- Uncontrolled hypertension (> 150 systolic, > 90 diastolic).
- Neurodegenerative diseases such as Parkinson's and Alzheimer disease.
- A history of chronic illnesses such as diabetes, cancer, rheumatologic diseases, immunodeficiency state, known cardiovascular disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or severe asthma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vascular effects of DE exposure
Time frame: One hour before and 1 hour after DE exposure
Brachial artery ultrasound was performed to measure vascular effects of DE exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Environmental Protection Agency (EPA) 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 3 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular effects of DE exposure (time frame: One hour before and 1 hour after DE exposure). 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 3 Sep 2025.