Effect of Diesel Exhaust Particulate Exposures on Endothelial Function in Humans
6 other identifiers
interventional
24
1 country
1
Brief Summary
Objectives: This proposal addresses the overall hypothesis that ambient fine particulate matter exerts cardiovascular health effects via alteration of endothelial homeostasis, through a mechanism mediated by oxidative stress. This project will use a controlled human inhalation exposure to diesel exhaust particulate (DEP) as a model to address the following objectives: 1) Determine whether exposure to inhaled DEP is associated with endothelial dysfunction in a concentration-related manner; 2) Determine whether exposure to inhaled DEP is associated with evidence of systemic oxidative stress; and 3) Determine whether antioxidant supplementation blunts the DEP effect on endothelial function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Jul 2008
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2006
CompletedFirst Posted
Study publicly available on registry
February 12, 2007
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedJanuary 16, 2013
January 1, 2013
2.1 years
August 25, 2006
January 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brachial artery caliber
Pre-exposure, immediate post-exposure
Secondary Outcomes (3)
Brachial Artery Flow-Mediated Dilation
Post-Exposure
Plasma Endothelin-1
Post-exposure (adjusted for pre-exposure level)
Serum IL-6
Post-exposure (adjusted for pre-exposure level)
Study Arms (2)
Diesel Exhaust
EXPERIMENTALFiltered Air
SHAM COMPARATORInterventions
NAC: 600mg twice daily for the day prior to exposure and 1x pre-exposure Ascorbate: 500mg twice daily for 7 days prior to exposure
matched appearance to acetylcysteine and ascorbate intervention
Eligibility Criteria
You may qualify if:
- Healthy adults aged 18-49.
You may not qualify if:
- Nonsmokers, no history of hypertension, asthma, diabetes, hypercholesterolemia, or other chronic conditions requiring ongoing medical care. No recent history of antioxidant, vitamin/mineral/botanical, or fatty acid supplementation beyond a daily multi-vitamin.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Northlake Laboratory
Seattle, Washington, 98105, United States
Related Publications (1)
Cosselman KE, Krishnan RM, Oron AP, Jansen K, Peretz A, Sullivan JH, Larson TV, Kaufman JD. Blood pressure response to controlled diesel exhaust exposure in human subjects. Hypertension. 2012 May;59(5):943-8. doi: 10.1161/HYPERTENSIONAHA.111.186593. Epub 2012 Mar 19.
PMID: 22431582DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joel D Kaufman, M.D., MPH
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 25, 2006
First Posted
February 12, 2007
Study Start
July 1, 2008
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
January 16, 2013
Record last verified: 2013-01