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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| e-cigarette nic_O LT | Experimental | e-cigarette (without nicotine; low temperature) |
|
| e-cigarette Nic_1 LT | Experimental | e-cigarette (with nicotine; low temperature) |
|
| e-cigarette Nic_0 HT | Experimental | e-cigarette (without nicotine; high temperature) |
|
| e-cigarette NIC_1 HT | Experimental | e-cigarette (with nicotine; high temperature) |
|
| Tobacco cigarette | Active Comparator | Tobacco cigarette |
|
| Placebo | Placebo Comparator | No E-cigarettes, Nor tobocco cigarettes |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| e-cigarette (PG+VG without nicotine; low temperature) | Device |
| ||
| e-cigarette (PG+VG with nicotine; low temperature) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in subcutaneous flux | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Plasma and urine oxidative stress markers | 1 hour | |
| Change in aortic stiffness | 10 minutes | |
| Change in heart rate variability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Paul Van Vooren | Hospital Erasme | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasme Hospital | Brussels | Brabant | 1070 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29451806 | Derived | 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. |
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|
| Device |
|
| e-cigarette (PG+VG without nicotine; high temperature) | Device |
|
| e-cigarette (PG+VG with nicotine; high temperature) | Device |
|
| tobacco cigarette | Other |
|
| 10 minutes |
| Change in baroreflex sensitivity | 10 minutes |
| ID | Term |
|---|---|
| D000072137 | Vaping |
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D003972 | Diathermy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D006979 | Hyperthermia, Induced |
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