Cardiovascular Effects of Incremental Diesel Exhaust Inhalation in Middle-Aged Healthy GSTM1 Null Human Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Haiyan Tong, Environmental Protection Agency (EPA)
ClinicalTrials.gov Identifier:
NCT01548625
First received: March 5, 2012
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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.


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Environmental Protection Agency (EPA):

Enrollment: 6
Study Start Date: July 2007
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy middle-aged human volunteers

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy 50-75 year-old male and female subjects with GSTM1 null genotype.

Criteria

Inclusion Criteria:

  • Age 50-75 years old generally healthy male and female.
  • Normal resting ECG.
  • Oxygen saturation greater than 94% at the time of physical exam.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548625

Locations
United States, North Carolina
EPA Human Studies Facility
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Haiyan Tong, Principal Investigator, Environmental Protection Agency (EPA)
ClinicalTrials.gov Identifier: NCT01548625     History of Changes
Other Study ID Numbers: DE pilot
Study First Received: March 5, 2012
Last Updated: March 7, 2012
Health Authority: United States: Federal Government

Keywords provided by Environmental Protection Agency (EPA):
risk of cardiovascular events

ClinicalTrials.gov processed this record on September 30, 2014