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

Not Applicable

Completed

• Conditions: Cardiovascular Risk Factor
• Interventions: Other: tobacco cigarette; Device: 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)

• Registration Number: NCT03036644
• Lead Sponsor: Université Libre de Bruxelles

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-15
• Study First Submitted: 2017-01-27
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-30
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tobacco cigarette	tobacco cigarette	Tobacco cigarette
Placebo	e-cigarette (PG+VG without nicotine; low temperature)	No E-cigarettes, Nor tobocco cigarettes
e-cigarette nic_O LT	e-cigarette (PG+VG without nicotine; low temperature)	e-cigarette (without nicotine; low temperature)
e-cigarette Nic_1 LT	e-cigarette (PG+VG with nicotine; low temperature)	e-cigarette (with nicotine; low temperature)
e-cigarette Nic_0 HT	e-cigarette (PG+VG without nicotine; high temperature)	e-cigarette (without nicotine; high temperature)
e-cigarette NIC_1 HT	e-cigarette (PG+VG with nicotine; high temperature)	e-cigarette (with nicotine; high temperature)

Primary Outcome Measures

Name	Time	Method
Change in subcutaneous flux	1 hour

Secondary Outcome Measures

Name	Time	Method
Change in Plasma and urine oxidative stress markers	1 hour
Change in aortic stiffness	10 minutes
Change in heart rate variability	10 minutes
Change in baroreflex sensitivity	10 minutes

Trial Locations

Locations (1)

Erasme Hospital; 🇧🇪 Brussels, Brabant, Belgium