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

Université Libre de Bruxelles

Status: Completed

Conditions: Cardiovascular Risk Factor

Treatments: Device: e-cigarette (PG+VG with nicotine; high temperature); Other: tobacco cigarette; Device: e-cigarette (PG+VG with nicotine; low temperature); Device: e-cigarette (PG+VG without nicotine; high temperature); Device: e-cigarette (PG+VG without nicotine; low temperature)

Study type: Interventional

Funder types: Other

Identifiers

NCT03036644

P2017/028 / B406201630672

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

25 participants in 6 patient groups, including a placebo group

e-cigarette nic_O LT

Experimental group

Description:

e-cigarette (without nicotine; low temperature)

Treatment:

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

e-cigarette Nic_1 LT

Experimental group

Description:

e-cigarette (with nicotine; low temperature)

Treatment:

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

e-cigarette Nic_0 HT

Experimental group

Description:

e-cigarette (without nicotine; high temperature)

Treatment:

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

e-cigarette NIC_1 HT

Experimental group

Description:

e-cigarette (with nicotine; high temperature)

Treatment:

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

Tobacco cigarette

Active Comparator group

Description:

Tobacco cigarette

Treatment:

Other: tobacco cigarette

Placebo

Placebo Comparator group

Description:

No E-cigarettes, Nor tobocco cigarettes

Treatment:

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