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Trial record 1 of 1 for:    Health Effects of Occupational Exposure to Combustion Particles - a Study on Volunteers Performing as Train Conductors (BioTrack) | Copenhagen, Denmark
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Health Effects of Occupational Exposure to Combustion Particles - a Study on Volunteers Performing as Train Conductors (BioTrack)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03104387
Recruitment Status : Active, not recruiting
First Posted : April 7, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
National Research Centre for the Working Environment, Denmark
Information provided by (Responsible Party):
Peter Moller, University of Copenhagen

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cardiovascular Function Genotoxicity Other: Electric train Other: Diesel train Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Diesel Combustion Generated Air Pollution on Cardiovascular Function and Oxidatively Damaged DNA in Healthy Volunteers
Actual Study Start Date : May 16, 2017
Actual Primary Completion Date : September 30, 2018
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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].

  2. 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.

  3. 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]


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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]


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Legally competent subjects

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104387


Locations
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Denmark
University of Copenhagen
Copenhagen, Denmark
Sponsors and Collaborators
University of Copenhagen
National Research Centre for the Working Environment, Denmark
Investigators
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Principal Investigator: Peter Moller, PhD University of Copenhagen

Publications of Results:

Other Publications:
Karottki G, Loft S. Rapport vedroerende maaling af udsaettelse for ultrafine partikler blandt ansatte i DSB, 1-48, 2015.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peter Moller, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03104387    
Other Study ID Numbers: H-16033227
No grant number ( Other Grant/Funding Number: Danish Centre for Nanosafety II )
2015-57-0121 case SUND-2016-80 ( Other Identifier: Danish Data Protection Agency )
H-16033227 ( Other Identifier: Danish Committee on Health Research Ethics for the Capital Region )
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter Moller, University of Copenhagen:
Air pollution
Diesel exhaust
Ultrafine particles
Vascular function
Endothelium function
Heart rate variability
DNA damage