Longitudinal Acute Air Pollution Systemic Effects

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Filtered air; Other: Diesel Exhaust

• Registration Number: NCT02677662
• Lead Sponsor: Umeå University

Brief Summary

Air pollution continues to be a key global issue with many governments focusing great attention on air quality legislation because of its harmful environmental and health impacts. Whilst there is much that remains unknown about the mechanisms underlying the negative health effects of air pollution, it is generally acknowledged that air pollution exposure leads to an increase in cardiovascular, cerebrovascular and respiratory mortality and morbidity. The current study will investigate systemic effects during a 72 hour period after a controlled diesel exhaust exposure.

Detailed Description

Exposure to air pollution (both indoor and outdoor sources) contributes to the premature deaths of 7 million people each year, primarily linked to cardiovascular and respiratory conditions. Within the complex mixture which air pollution comprises, combustion derived particulate matter (PM) has been suggested as one of the most harmful components to the cardiopulmonary system. In urban areas PM derived from combustion originates largely from diesel vehicles.

Numerous experimental chamber studies have demonstrated respiratory as well as cardiovascular dysfunctions after the inhalation of diesel exhaust. Many of these dysfunctions are driven by inflammation and oxidative stress. There is much less knowledge concerning the systemic effects of diesel exhaust exposure, and especially over longer time courses than 24 hours.

The investigators aim to investigate the time course of systemic effects (such as markers of inflammation, cardiovascular dysfunction, and oxidative stress) in blood and urine samples taken after a diesel exhaust exposure. The effects of exercise or rest in an experimental chamber exposure will also be investigated.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-02-08
• Study First Posted: 2016-02-09
• Primary Completion: 2016-03
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Normal clinical examination
• Normal EKG
• Normal routine blood tests
• Normal lung function
• Normal skinprick test

Exclusion Criteria

• Cardiovascular disease
• Diabetes Mellitus
• Asthma and/or allergy
• Smoking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Filtered air exposure	Filtered air	2 hour exposure to filtered air during intermittent exercise or rest.
Diesel exhaust exposure	Diesel Exhaust	2 hour exposure to dilute diesel exhaust (approximate PM10 (particulate matter\<10um) concentration 300 mcg/m3) during intermittent exercise or rest.

Primary Outcome Measures

Name	Time	Method
Inflammatory biomarkers	72 hours	In blood samples (total and differential counts

Secondary Outcome Measures

Name	Time	Method
Oxidative stress markers	72 hours	In blood samples (ox-LDL, ROS)
Cardiovascular biomarkers	72 hours	In blood samples (sTM, hsCRP, syndecan-1)
Metabolomics	72 hours	Mass spectrometry based metabolomics in blood samples

Trial Locations

Locations (1)

Umeå University; 🇸🇪 Umeå, Sweden