Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID04098536

Acute Exposure to Diesel: Prolonged Effects on Inflammation and Vasculature

Led by University of Athens · Updated on 2019-09-24

40

Participants Needed

2

Research Sites

104 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are investigating the impact of short-term exposure to diesel exhaust fumes on inflammation and blood vessel function in healthy adults. This randomized, double-blind, crossover study aims to understand how brief diesel exposure may affect arterial stiffness, vascular function, and inflammatory markers related to atherosclerosis. Diesel exhaust is a common urban pollutant linked to cardiovascular and respiratory diseases, but the mechanisms and effects of acute exposure remain unclear. Participants will attend two sessions spaced four weeks apart, during which they will be exposed for two hours to either controlled diesel exhaust fumes or filtered air. Measurements will be taken before exposure, immediately after, and 24 hours later. These include tests of endothelial function using flow mediated dilation, arterial stiffness via pulse wave velocity and augmentation index, heart rate variability to assess sympathetic activity, and blood tests for inflammatory and fibrinolytic markers like C-reactive protein, fibrinogen, protein C, and protein S. During the study, participants will undergo various evaluations such as ultrasound scans, blood pressure assessments, continuous electrocardiographic monitoring, and blood sampling. They will be asked to avoid alcohol, caffeine, smoking, and medication affecting the cardiovascular system. The study monitors changes over 24 hours post-exposure to assess prolonged effects. Total participation includes two exposure visits and follow-up measurements to evaluate vascular and inflammatory responses to diesel fumes.

CONDITIONS

Brief Title

Acute Exposure to Diesel: Prolong Effects on Inflammation and Vasculature

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy subjects
  • Age between 18 and 60 years
Not Eligible

You will not qualify if you...

  • Presence of chronic cardiovascular diseases
  • Presence of chronic respiratory diseases
  • Pregnancy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Exposure Sessions

Duration - Approximately 4 weeks (two sessions 4 weeks apart)

Participants undergo two 2-hour exposure sessions to either diesel exhaust fumes or filtered air, spaced 4 weeks apart, to assess vascular function and inflammatory responses.

2 visits (each 2-hour exposure, in-person)

Post-Exposure Assessments

Duration - 24 hours after each exposure session

Participants have measurements of vascular function, sympathetic activity, and inflammatory markers at baseline, immediately after exposure, and 24 hours post-exposure for each session.

3 assessments per session (before exposure, immediately after, and 24 hours after exposure)

Trial Site Locations

Total: 2 locations

1

1st Cardiology Department, Hippokration General Hospital

Athens, Attica, Greece, 11528

Actively Recruiting

2

Evangelos Oikonomou

Athens, Please Select, Greece, 17122

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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