Clinical trial NCT05454930: Effect of Commute Traffic on Vascular Function
Official title: Effect of Commute Traffic on Vascular Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: air pollution
traffic
vascular function
gasoline exhaust
diesel exhaust
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Environmental Protection Agency (EPA)
name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2022-07-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The investigators will assess the vascular effects of riding in a car in heavily trafficked roadways, and whether filtering the car's air reduces those effects.

Detailed description: In this double-blind, crossover trial, randomized to order, recruited participants will be screened and then will accompany the study team on three typical commutes on separate days with sufficient washout (i.e., three weeks) between drives. One day this will occur with an effective filter system in the vehicle and the other two days without effective filtration; ineffective filtration is the most typical actual vehicle condition. Subjects will be unaware of the filtration conditions of the commute on that day. Each subject's experimental sessions will occur at the same time of day and will be separated by at least 21 days. The two sessions (either filtered air or traffic-derived entrained air) will be 120 minutes in duration and will encompass routes on heavily traveled roadways in the Seattle area. Before subjects begin the commute trials, they will go through the consent process and a series of screening tests. The study investigators will assess a series of measures regarding vascular function before and after each drive.

Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

* asthma,
* high blood pressure,
* diabetes,
* high cholesterol,
* other chronic conditions requiring ongoing medical care.

Primary outcomes:
measure: Change in Brachial Artery Diameter from Pre-Drive to Post-Drive
timeFrame: 30 minutes before 120 minute driving session; 30 minutes post driving session
measure: Change in Blood Pressure from Pre-Drive to During-Drive and Post-drive
timeFrame: 10 minutes before driving session; 15, 30, 45, 60, 75, 90, 100, 120 minutes following start of (120 minute) driving session; 10 minutes, 1.5 hours, 3.5 hours, 6 hours, 24 hours after end of driving session.
measure: Change in Retinal Arteriolar Diameter from Pre-Drive to Post-Drive
timeFrame: 30 minutes before 120 minute driving session; 30 minutes post driving session
measure: Gene Expression and DNA methylation
timeFrame: 30 minutes before 120 minute driving session; 30 minutes, 5 hour, and 24 hours post-driving session
Secondary outcomes:
measure: circulating stress hormone
timeFrame: 30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
measure: complete blood count with differential
timeFrame: 30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
measure: inflammatory marker interleukin-6
timeFrame: 30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
measure: inflammatory marker c-reactive protein
timeFrame: 30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Joel Kaufman, MD
role: PRINCIPAL_INVESTIGATOR
References: