Health TrialsbyHealthPanel

Acute Exposure to Diesel: Prolong Effects on Inflammation and Vasculature

ConditionAtherosclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Athens

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy subjects

Disqualifiers

Chronic diseases Cardiovascular diseases Respiratory diseases Pregnacy

Trial design

Design model

Crossover

Treatments tested in this trial

  • Diesel exhaust

    Behavioral

    Exposure to diesel exhaust fumes

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Diesel ExposureExperimental treatment 1 intervention
Group B: Filtered Air ExposurePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Endothelial function assesment

The following outcome will be evaluated Changes over time of : Flow mediated dilation (FMD) mesured in the branchial artery with ultrasound. Units %

Time frame
24 hours
2

Arterial Stifness

The following outcome will be evaluated Changes over time of : Carotid-femoral pulse wave velocity (PWV), measured non invasively Units: m/sec

Time frame
24 hours

Secondary outcomes

1

Sympathetid Activity

Change over time of Standard deviation of ECG RR intervals Units: msec

Time frame
24 hours
2

Inflammation

Cgange over time of C reactive protein levels Units Mg/dl

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Athens

Lead sponsor

Source ClinicalTrials.gov
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