Diesel Exhaust and Vascular Function
NCT01508637 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2015-08-03
Summary
Double-blind, sham- and placebo-controlled randomized study of effects of freshly-generated diluted diesel exhaust inhalation on vascular function. To examine role of adrenergic system a trial of alpha-blocker terazosin is also used. Each participant completes four study sessions, separated by at least three weeks: 1) Diesel exhaust inhalation (DE, controlled at 300 micrograms/cubic meter for two hours) and terazosin (2 mg prior to inhalation exposure); 2) DE plus placebo (matched for terazosin); 3) filtered air plus terazosin; and 4) filter air plus placebo. The investigators assess outcomes of blood pressure, forearm brachial artery ultrasound, and plasma measures of endothelial activation. The investigators hypothesize that DE exposure will be associated with increased blood pressure, decreased brachial artery diameter, and increased circulating endothelins, and that these effects will be attenuated by terazosin administration.
Conditions
- Cardiovascular Effects
Interventions
- OTHER
-
Diesel Exhaust
Freshly generated diesel exhaust, diluted to 300 micrograms/cubic meter. Exposures are two hours in duration.
- OTHER
-
Filtered Air
Sham exposure, identical to conditions of diesel exhaust exposure, but with only air filtered of particles and volatile organic compound gases
- DRUG
-
Terazosin
2 mg by mouth, 90 minutes prior to exposure initiation
- DRUG
-
capsule, identical in appearance to terazosin capsule, by mouth, 30 minutes prior to exposure initiation
Sponsors & Collaborators
-
National Institute of Environmental Health Sciences (NIEHS)
collaborator NIH -
Environmental Protection Agency (EPA)
collaborator FED - lead OTHER
Principal Investigators
-
Joel D Kaufman, MD, MPH · University of Washington
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 49 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-01-31
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
Countries
- United States
Study Locations
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