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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk Factor
• Intervention / Treatment: 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); Other: tobacco cigarette

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brabant
    • Brussels, Brabant, Belgium, 1070
      • Erasme Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: e-cigarette nic_O LT; e-cigarette (without nicotine; low temperature)	Device: e-cigarette (PG+VG without nicotine; low temperature)
Experimental: e-cigarette Nic_1 LT; e-cigarette (with nicotine; low temperature)	Device: e-cigarette (PG+VG with nicotine; low temperature)
Experimental: e-cigarette Nic_0 HT; e-cigarette (without nicotine; high temperature)	Device: e-cigarette (PG+VG without nicotine; high temperature)
Experimental: e-cigarette NIC_1 HT; e-cigarette (with nicotine; high temperature)	Device: e-cigarette (PG+VG with nicotine; high temperature)
Active Comparator: Tobacco cigarette	Other: tobacco cigarette
Placebo Comparator: Placebo; No E-cigarettes, Nor tobocco cigarettes	Device: e-cigarette (PG+VG without nicotine; low temperature)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in subcutaneous flux	1 hour

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Université Libre de Bruxelles
• Investigators: Study Director: Jean-Paul Van Vooren, Hospital Erasme

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: January 27, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimate): January 30, 2017

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: electronic cigarette; oxidative stress; e-cigarette; tobacco smoking
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: P2017/028 / B406201630672

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No