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

NCT ID: NCT03036644

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-15

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Cardiovascular Risk Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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e-cigarette nic_O LT

e-cigarette (without nicotine; low temperature)

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

e-cigarette Nic_1 LT

e-cigarette (with nicotine; low temperature)

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

e-cigarette Nic_0 HT

e-cigarette (without nicotine; high temperature)

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

e-cigarette NIC_1 HT

e-cigarette (with nicotine; high temperature)

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Tobacco cigarette

Tobacco cigarette

Group Type ACTIVE_COMPARATOR

tobacco cigarette

Intervention Type OTHER

Placebo

No E-cigarettes, Nor tobocco cigarettes

Group Type PLACEBO_COMPARATOR

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

Intervention Type DEVICE

Interventions

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

tobacco cigarette

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université Libre de Bruxelles

OTHER

Sponsor Role lead

Responsible Party

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Martin Chaumont

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean-Paul Van Vooren

Role: STUDY_DIRECTOR

Hospital Erasme

Locations

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Erasme Hospital

Brussels, Brabant, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 29451806 (View on PubMed)

Other Identifiers

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P2017/028 / B406201630672

Identifier Type: -

Identifier Source: org_study_id