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Acute Exposure to Diesel: Prolong Effects on Inflammation and Vasculature (DEVA)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098536
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Dimitris Tousoulis, University of Athens

Brief Summary:
Cross-over double-blind study. Healthy subjects will be exposed to diesel exhaust fumes and/or filtered air during a 2-hour session. Several parameters will be assesed i.e. endothelial function will be assessed with flow mediated dilation (FMD) techniques, arterial stiffness with pulse wave velocity (PWV) and reflected waves with augmentation index (AIx). C reactive protein (CRP), fibrinogen, protein C levels and protein S activity will be also measured. Heart rate variability and standard deviation of normal to normal intervals R-R intervals (SDNN) will be used to assess sympathetic activity. Measurements were assessed before, 2 and 24 hours after diesel exposure.

Condition or disease Intervention/treatment Phase
Atherosclerosis Behavioral: Diesel exhaust Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Cross over double blind
Masking: Double (Participant, Investigator)
Masking Description: Double blind
Primary Purpose: Prevention
Official Title: Acute Exposure to Diesel: Prolong Effects on Inflammation and Vasculature
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2026

Arm Intervention/treatment
Experimental: Diesel Exposure Behavioral: Diesel exhaust
Exposure to diesel exhaust fumes
Other Name: Filtered air exposure

Placebo Comparator: Filtered Air Exposure Behavioral: Diesel exhaust
Exposure to diesel exhaust fumes
Other Name: Filtered air exposure




Primary Outcome Measures :
  1. Endothelial function assesment [ Time Frame: 24 hours ]

    The following outcome will be evaluated

    Changes over time of :

    Flow mediated dilation (FMD) mesured in the branchial artery with ultrasound. Units %


  2. Arterial Stifness [ Time Frame: 24 hours ]

    The following outcome will be evaluated

    Changes over time of :

    Carotid-femoral pulse wave velocity (PWV), measured non invasively Units: m/sec



Secondary Outcome Measures :
  1. Sympathetid Activity [ Time Frame: 24 hours ]
    Change over time of Standard deviation of ECG RR intervals Units: msec

  2. Inflammation [ Time Frame: 24 hours ]
    Cgange over time of C reactive protein levels Units Mg/dl



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects

Exclusion Criteria:

  • Chronic diseases Cardiovascular diseases Respiratory diseases Pregnacy

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): NCT04098536


Locations
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Greece
1st Cardiology Department, Hippokration General Hospital Recruiting
Athens, Attiki, Greece, 11528
Contact: Manina Anastasopoulou    +2132088026    manastas@med.uoa.gr   
Evangelos Oikonomou Recruiting
Athens, Please Select, Greece, 17122
Contact: Evangelos Oikonomou, MD    +306947701299    boikono@gmail.com   
Contact: Dimitris Tousoulis, MD, PhD    +2132088026    manastas@med.uoa.gr   
Sponsors and Collaborators
University of Athens
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Responsible Party: Dimitris Tousoulis, Professor Dimitris Tousoulis, University of Athens
ClinicalTrials.gov Identifier: NCT04098536    
Other Study ID Numbers: 14/20/7/2016
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atherosclerosis
Inflammation
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases