Diesel Exhaust and Vascular Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiovascular Effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Diesel Exhaust + Terazosin

Group Type EXPERIMENTAL

Diesel Exhaust

Intervention Type OTHER

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

Terazosin

Intervention Type DRUG

2 mg by mouth, 90 minutes prior to exposure initiation

Diesel Exhaust + placebo

Group Type EXPERIMENTAL

Diesel Exhaust

Intervention Type OTHER

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

placebo

Intervention Type DRUG

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

Filtered Air + terazosin

Group Type SHAM_COMPARATOR

Filtered Air

Intervention Type OTHER

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

Terazosin

Intervention Type DRUG

2 mg by mouth, 90 minutes prior to exposure initiation

Filtered air + placebo

Group Type SHAM_COMPARATOR

Filtered Air

Intervention Type OTHER

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

placebo

Intervention Type DRUG

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

Interventions

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Diesel Exhaust

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

Intervention Type OTHER

Filtered Air

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

Intervention Type OTHER

Terazosin

2 mg by mouth, 90 minutes prior to exposure initiation

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes