Recruiting

Observational Study

Sponsor:

University of Washington

Code:

NCT01508637

Conditions

Cardiovascular Effects

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

Interventions

Diesel Exhaust

Filtered Air

Terazosin

placebo

Study Details

Brief 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

Study ID

NCT01508637

Start date

Jan, 2012

Status verified date

Jul, 2015

Completion date

Dec, 2015

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

Inclusion Criteria:

  • healthy without chronic illness
  • Body Mass Index 18.5 - 26.0
  • tolerates 2 mg terazosin dose without unacceptable symptoms
  • able to return for four exposure sessions

Exclusion Criteria:

  • any chronic disease
  • tobacco user
  • asthma
  • elevated cholesterol
  • obesity
  • hypertension
  • diabetes
  • any chronic cardiovascular or pulmonary disease
  • pregnancy or unwillingness to use effective contraception, if female

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Diesel Exhaust + Terazosin

experimental: Diesel Exhaust + placebo

sham comparator: Filtered Air + terazosin

sham comparator: Filtered air + placebo

Interventions

Diesel Exhaust

Freshly generated diesel exhaust, diluted to 300 micrograms/cubic meter. Exposures are two hours in duration.

Filtered Air

Sham exposure, identical to conditions of diesel exhaust exposure, but with only air filtered of particles and volatile organic compound gases

Terazosin

2 mg by mouth, 90 minutes prior to exposure initiation

placebo

capsule, identical in appearance to terazosin capsule, by mouth, 30 minutes prior to exposure initiation

Primary outcome measure

  • Systolic Blood Pressure [ Time Frame: 30-90 minutes after exposure initiation ]

Central Contacts and Locations

Central contacts

Locations

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

More Information

Sponsor

University of Washington

Last update posted

Aug 3, 2015

Last verified

Jul, 2015

Keywords

  • air pollution
  • vasoconstriction
  • blood pressure
  • diesel exhaust

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2015-08-03.