Clinical trial NCT03036644: Comparison of Electronic Cigarettes and Tobacco Cigarettes on Cardiovascular Function and Oxidative Stress
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Keywords: electronic cigarette
e-cigarette
oxidative stress
tobacco smoking
Lead sponsor: Université Libre de Bruxelles
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in subcutaneous flux
timeFrame: 1 hour
Secondary outcomes:
measure: Change in Plasma and urine oxidative stress markers
timeFrame: 1 hour
measure: Change in aortic stiffness
timeFrame: 10 minutes
measure: Change in heart rate variability
timeFrame: 10 minutes
measure: Change in baroreflex sensitivity
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
state: Brabant
Study officials:
affiliation: Hospital Erasme
name: Jean-Paul Van Vooren
role: STUDY_DIRECTOR
References:
citation: Chaumont M, Bernard A, Pochet S, Melot C, El Khattabi C, Reye F, Boudjeltia KZ, Van Antwerpen P, Delporte C, van de Borne P. High-Wattage E-Cigarettes Induce Tissue Hypoxia and Lower Airway Injury: A Randomized Clinical Trial. Am J Respir Crit Care Med. 2018 Jul 1;198(1):123-126. doi: 10.1164/rccm.201711-2198LE. No abstract available.