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

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ClinicalTrials.gov Identifier: NCT03036644
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Martin Chaumont, 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.


Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : January 15, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes Smoking

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
Tobacco cigarette
Other: tobacco cigarette
Placebo Comparator: Placebo
No E-cigarettes, Nor tobocco cigarettes
Device: e-cigarette (PG+VG without nicotine; low temperature)



Primary Outcome Measures :
  1. Change in subcutaneous flux [ Time Frame: 1 hour ]

Secondary Outcome Measures :
  1. Change in Plasma and urine oxidative stress markers [ Time Frame: 1 hour ]
  2. Change in aortic stiffness [ Time Frame: 10 minutes ]
  3. Change in heart rate variability [ Time Frame: 10 minutes ]
  4. Change in baroreflex sensitivity [ Time Frame: 10 minutes ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036644


Contacts
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Contact: Philippe Van de Borne, MD, PhD +32 (0)2 555 56 64 Philippe.Van.de.Borne@erasme.ulb.ac.be

Locations
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Belgium
Erasme Hospital Recruiting
Brussels, Brabant, Belgium, 1070
Sponsors and Collaborators
Université Libre de Bruxelles
Investigators
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Study Director: Jean-Paul Van Vooren Hospital Erasme

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Responsible Party: Martin Chaumont, Principal investigator, Université Libre de Bruxelles
ClinicalTrials.gov Identifier: NCT03036644     History of Changes
Other Study ID Numbers: P2017/028 / B406201630672
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Martin Chaumont, Université Libre de Bruxelles:
electronic cigarette
e-cigarette
oxidative stress
tobacco smoking

Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action