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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03036644
Enrollment
25
Registered
2017-01-30
Start date
2017-01-15
Completion date
2019-12-31
Last updated
2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factor

Keywords

electronic cigarette, e-cigarette, oxidative stress, tobacco smoking

Brief 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.

Interventions

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)

Sponsors

Université Libre de Bruxelles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change in subcutaneous flux1 hour

Secondary

MeasureTime frame
Change in Plasma and urine oxidative stress markers1 hour
Change in aortic stiffness10 minutes
Change in heart rate variability10 minutes
Change in baroreflex sensitivity10 minutes

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026