Health Effects of Occupational Exposure to Combustion Particles - a Study on Volunteers Performing as Train Conductors (BioTrack)

University of Copenhagen

Status: Completed

Conditions: Cardiovascular Function; Genotoxicity

Treatments: Other: Diesel train; Other: Electric train

Study type: Interventional

Funder types: Other

Identifiers

NCT03104387

H-16033227 (Other Identifier)

2015-57-0121 case SUND-2016-80 (Other Identifier)

No grant number

Details and patient eligibility

About

Ambient air pollution is a complex mixture of gaseous pollutants and particulate matter (PM). PM has a recognized important role in human health. There is a strong scientific consensus on the independent association of PM and adverse cardiovascular and respiratory effects, as well as cancer. It is reasonable to expect that the smaller particles (ultrafine particles, UFP) may have an enhanced toxicity relative to other PM size fractions, due to physical properties and potential to translocation beyond the lung.

A recent Danish report concluded that train conductors on a working day, and in two specific diesel engine trains, are exposed to higher concentrations of diesel exhaust than by constant stay in a busy street. Indeed, the average exposure for train conductors on such engines was around 100,000-150,000 UFP per cm3 as compared with around 40,000 per cm3 on a busy street in Copenhagen [1]. The aim of this study is to investigate if this occupational exposure is associated with vascular and respiratory impairment and DNA damage.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers
• Legally competent subjects

Exclusion criteria

• Current smokers
• Pregnancy
• Alcohol and drug abuse
• Prescriptionary use of anti-inflammatory or cardiovascular medication

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Diesel train - exposure scenario

Experimental group

Description:

The same study person will be exposed to two different scenarios, at different times and for three consecutive days. It will be a lag time of 2 weeks between each exposure scenario. The "exposure" scenario is defined as a workday (6 hours) on the diesel ME-driven model regional train. The Diesel Train Scenario is performed twice. After the scenario completion (on the third day in defined train routes) the vascular function, lung function, blood and urine samplings are performed.

Treatment:

Other: Diesel train

Electric train - low exposure scenario

Sham Comparator group

Description:

The same study person will be exposed to two different scenarios, at different times and for three consecutive days. It will be a lag time of 2 weeks between each exposure scenario. The "low exposure" scenario is defined as a workday (6 hours) on the electric train. The Diesel Train Scenario is performed twice. After the scenario completion (on the third day in defined train routes) the vascular function, lung function, blood and urine samplings are performed.

Treatment:

Other: Electric train