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

August 7, 2020 updated by: Peter Moller, University of Copenhagen

Effects of Diesel Combustion Generated Air Pollution on Cardiovascular Function and Oxidatively Damaged DNA in Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers
  • Legally competent subjects

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Diesel train - exposure scenario
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.
Other: Diesel train
Exposure to air with high level of ultrafine particles (Diesel train)
SHAM_COMPARATOR: Electric train - low exposure scenario
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.
Other: Electric train
Exposure to air with low level of ultrafine particles (Electric train)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reactive hyperemia index measured by peripheral arterial tonometry
Time Frame: Peripheral arterial tonometry is assessed after each exposure scenario (on the third day after 6 hours on defined train routes per day)
The primary outcome will be measured in the form of post-ischemic variation followed by the measurement of the vasomotor function after the administration of nitroglycerin, to allow the investigation of the endothelium independent vasodilatation. The portable device EndoPAT 2000 will be used (Itamar Medical Ltd, Israel) [2-6].
Peripheral arterial tonometry is assessed after each exposure scenario (on the third day after 6 hours on defined train routes per day)
Heart rate variability
Time Frame: Assessed after each exposure scenario (on the third day after 6 hours on defined train routes per day)
Heart rate variability is measured with the EndoPAT 2000 device during baseline recording. It includes time domain measures (SDNN, pNN50 and RMSSD), high (HF) and low frequency (LF) components as well as LF/HF ratio, based on measurements over 5 minutes.
Assessed after each exposure scenario (on the third day after 6 hours on defined train routes per day)
DNA damage in peripheral blood mononuclear cells
Time Frame: Blood is sampled, prepared and stored after each exposure scenario (on the third day after 6 hours on defined train routes per day). Analysis is performed after sample collection completion.
The levels of strand breaks and formamidopyrimidine-DNA-glycosylase (FPG) sites are measured with the single cell gel electrophoresis assay (comet assay) [7-13]
Blood is sampled, prepared and stored after each exposure scenario (on the third day after 6 hours on defined train routes per day). Analysis is performed after sample collection completion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung function
Time Frame: The lung function is assessed after each exposure scenario (on the third day after 6 hours on defined train routes per day)
The lung function is measured with EasyOne 2001 spirometer device (Switzerland). Lung function measurements includes forced vital capacity (FVC), forced expiratory volume after 1 second (FEV1), peak expiratory flow (PEF) and FEV1/FVC.
The lung function is assessed after each exposure scenario (on the third day after 6 hours on defined train routes per day)
Systemic inflammatory markers
Time Frame: Blood is sampled, prepared and stored after each exposure scenario (on the third day after 6 hours on defined train routes per day). Analysis is performed after sample collection completion.
Acute phase reactants, pro-inflammatory cytokines and cell adhesion molecules
Blood is sampled, prepared and stored after each exposure scenario (on the third day after 6 hours on defined train routes per day). Analysis is performed after sample collection completion.
Urinary excretion of 1-hydroxypyrene
Time Frame: Morning urine is sampled, prepared and stored after each exposure scenario (on the morning of the third day after two days with 6 hours on defined train routes). Analysis is performed after sample collection completion.
The urinary biomarker of exposure to polycyclic aromatic hydrocarbons, 1-hydroxypyrene, is measured with reverse-phase HPLC and standardized for diuresis with the concentration of creatinine
Morning urine is sampled, prepared and stored after each exposure scenario (on the morning of the third day after two days with 6 hours on defined train routes). Analysis is performed after sample collection completion.
Serum/plasma bioactivity
Time Frame: Blood is sampled, prepared and serum is stored after each exposure scenario (on the third day after 6 hours on defined train routes per day). Analysis is performed after sample collection completion.
To assess the potential effects on vascular and endothelial function [14, 15]
Blood is sampled, prepared and serum is stored after each exposure scenario (on the third day after 6 hours on defined train routes per day). Analysis is performed after sample collection completion.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Augmentation index
Time Frame: Assessed after each exposure scenario (on the third day after 6 hours on defined train routes per day)
Measured with the EndoPAT 2000 device during baseline recording.
Assessed after each exposure scenario (on the third day after 6 hours on defined train routes per day)
Blood pressure
Time Frame: Assessed after each exposure scenario (on the third day after 6 hours on defined train routes per day)
Measured with an aneroid sphygmomanometer.
Assessed after each exposure scenario (on the third day after 6 hours on defined train routes per day)
Heart rate
Time Frame: Assessed after each exposure scenario (on the third day after 6 hours on defined train routes per day)
Measured with the EndoPAT 2000 device during baseline recording.
Assessed after each exposure scenario (on the third day after 6 hours on defined train routes per day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

National Research Centre for the Working Environment, Denmark

Investigators

  • Principal Investigator: Peter Moller, PhD, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 16, 2017

Primary Completion (ACTUAL)

September 30, 2018

Study Completion (ACTUAL)

May 1, 2020

Study Registration Dates

First Submitted

March 23, 2017

First Submitted That Met QC Criteria

March 31, 2017

First Posted (ACTUAL)

April 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 10, 2020

Last Update Submitted That Met QC Criteria

August 7, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-16033227 (OTHER: Danish Committee on Health Research Ethics for the Capital Region)
  • No grant number (Other Grant/Funding Number: The Swedish Society of Spinal Surgeons)
  • 2015-57-0121 case SUND-2016-80 (OTHER: Danish Data Protection Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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