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Completed

NCT Number: NCT03036644

Comparison of Electronic Cigarettes and Tobacco Cigarettes on Cardiovascular Function and Oxidative Stress

Background: Electronic cigarettes (e-cigarettes) are battery-powered devices heating a liquid (e-liquid) composed of propylene glycol and/or vegetable glycerin, and most commonly, nicotine to form an aerosol (vapor) that is inhaled (i.e. "vaped"). Scarce and conflicting data are available regarding the cardiovascular toxicity of e-cigarettes. We wish to determine the acute effects of propylene glycol/vegetable glycerin and nicotine vaporization at high temperature in comparison to tobacco cigarette smoking on several advanced cardiovascular parameters in healthy chronic e-cigarettes users and tobacco smokers. Furthermore, a large range of plasma, urine and respiratory oxidative stress markers will be quantified. By this way, we aim to demonstrate that e-cigarettes-induced systemic oxidative stress could be linked to cardiovascular toxicity. To the best of our knowledge, this is the first project that evaluates the effects of e-cigarettes vaping in comparison to tobacco cigarette smoking on the cardiovascular system in relation to vaporization temperature, nicotine delivery and oxidative stress.

Aims of the study: This study tests the following hypotheses: 1) acute high temperature vaporization of propylene glycol and vegetable glycerin has no deleterious effects on cardiovascular parameters in comparison to tobacco smoking; 2) Tobacco smoking rises plasma and urine oxidative stress biomarkers. On the contrary, acute and chronic e-cigarettes vaping don't rise these biomarkers. At a cellular level, plasma of smokers but not vapers increases superoxide anion production.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasme Hospital

Brussels, Brabant, 1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects

Exclusion criteria

  • Any form of cardiovascular disease
  • Any form of pulmonary disease like asthma or COPD
  • Any form of systemic or chronic disorder
  • Active allergy within 4 weeks of the study
  • Symptoms of infection or inflammation within 4 weeks of the study
  • Pregnancy

Treatment and study plan

e-cigarette (PG+VG without nicotine; low temperature)

Device

e-cigarette (PG+VG with nicotine; low temperature)

Device

e-cigarette (PG+VG without nicotine; high temperature)

Device

e-cigarette (PG+VG with nicotine; high temperature)

Device

Tobacco Cigarette

Other

Primary outcomes

  1. Change in subcutaneous flux

    Time frame: 1 hour

Secondary outcomes

  1. Change in Plasma and urine oxidative stress markers

    Time frame: 1 hour

  2. Change in aortic stiffness

    Time frame: 10 minutes

  3. Change in heart rate variability

    Time frame: 10 minutes

  4. Change in baroreflex sensitivity

    Time frame: 10 minutes

Sponsors and collaborators

Lead sponsor

Université Libre de Bruxelles

Other

Registry information

Official study title

Effects of Electronic Cigarette Vaporization at High Temperature in Comparison to Tobacco Smoking on Cardiovascular Function and Oxidative Stress in Electronic Cigarette Users and Regular Tobacco Smokers

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2017
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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