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

NCT03036644 | Completed DMC

• 1 other identifier: P2017/028 / B406201630672
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Risk Factor

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in subcutaneous flux

  1 hour

Secondary Outcomes (4)

• 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

Study Arms (6)

e-cigarette nic_O LT

EXPERIMENTAL

e-cigarette (without nicotine; low temperature)

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

e-cigarette Nic_1 LT

EXPERIMENTAL

e-cigarette (with nicotine; low temperature)

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

e-cigarette Nic_0 HT

EXPERIMENTAL

e-cigarette (without nicotine; high temperature)

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

e-cigarette NIC_1 HT

EXPERIMENTAL

e-cigarette (with nicotine; high temperature)

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

Tobacco cigarette

ACTIVE COMPARATOR

Tobacco cigarette

Other: tobacco cigarette

Placebo

PLACEBO COMPARATOR

No E-cigarettes, Nor tobocco cigarettes

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

Interventions

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

Placebo; e-cigarette nic_O LT

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

e-cigarette Nic_1 LT

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

e-cigarette Nic_0 HT

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

e-cigarette NIC_1 HT

tobacco cigarette OTHER

Tobacco cigarette

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Libre de Bruxelles: lead

Study Sites (1)

Erasme Hospital

Brussels, Brabant, 1070, Belgium

Location

Related Publications (1)

• 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.

  PMID: 29451806 DERIVED

MeSH Terms

Conditions

Vaping; Tobacco Smoking

Interventions

Tobacco Use Cessation Devices; Diathermy

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Therapeutics; Hyperthermia, Induced

Study Officials

• Jean-Paul Van Vooren

  Hospital Erasme

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: January 30, 2017
• Study Start: January 15, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)