Clinical Trials Directory

Trials / Completed

CompletedNCT03036644

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
25 (actual)
Sponsor
Université Libre de Bruxelles · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICEe-cigarette (PG+VG without nicotine; low temperature)
DEVICEe-cigarette (PG+VG with nicotine; low temperature)
DEVICEe-cigarette (PG+VG without nicotine; high temperature)
DEVICEe-cigarette (PG+VG with nicotine; high temperature)
OTHERtobacco cigarette

Timeline

Start date
2017-01-15
Primary completion
2019-12-31
Completion
2019-12-31
First posted
2017-01-30
Last updated
2020-11-03

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03036644. Inclusion in this directory is not an endorsement.

Comparison of Electronic Cigarettes and Tobacco Cigarettes on Cardiovascular Function and Oxidative Stress (NCT03036644) · Clinical Trials Directory