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

Cardiovascular Risk Factor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03036644
• Other study ID #: P2017/028 / B406201630672
• Status: Completed
• Phase: N/A
• Start date: January 15, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2020
• Source: Université Libre de Bruxelles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

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

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

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

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

Other:
• tobacco cigarette

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Brussels	Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Université Libre de Bruxelles

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in subcutaneous flux		1 hour
Secondary	Change in Plasma and urine oxidative stress markers		1 hour
Secondary	Change in aortic stiffness		10 minutes
Secondary	Change in heart rate variability		10 minutes
Secondary	Change in baroreflex sensitivity		10 minutes