Acute Vascular Effects of E-cigarette Use
NCT03746119 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2019-09-30
Summary
Tobacco use harms nearly every organ in the body and has been linked to ischemic heart disease, chronic obstructive pulmonary disease, stroke, respiratory illness, lung cancer and other cancers. The World Health Organization estimates that 6 million people worldwide lose their lives due to tobacco use yearly, making cigarette smoking one of the leading single causes of preventable death and morbidity.
As this knowledge becomes more common and wide-spread the sales of cigarettes has seen a decrease in recent years. On account of this, the electronic cigarette (e-cigarette) has been introduced to the market as an alternative to traditional cigarette smoking. Electronic cigarettes, also known as e-cigarettes or e-cigs, are delivery devices which heat a base liquid, to which nicotine and flavorings can be added, into vapor which is then inhaled ("vaping"). E-cigarettes have been aggressively marketed as a cheaper, healthier, cleaner alternative to smoking in both advertising and media outlets, primarily targeting adolescents.
Despite growing e-cigarette use, scientific data on health effects are insufficient in some respects and completely lacking in others. However, the investigators have recently shown that cigarette smoking, as well as e-cigarette inhalation, both cause an acute increase of endothelial progenitor cells (EPCs) in the blood of healthy volunteers, suggesting vascular injury, inflammation and a negative impact on hemostasis.
Therefore, using well validated methods, including forearm plethysmography, biomarkers in blood, arterial stiffness measurements and microcirculation assessment (GlycoCheck), the investigators aim to further investigate the effects of e-cigarette inhalation on the vascular system. These measurements will be performed before and after healthy subjects inhale vapor from a e-cigarette on two separate occasions, with and without nicotine in a double-blinded, randomized protocol.
Conditions
- Healthy
Interventions
- OTHER
-
E-cigarette vapor containing nicotine
A fourth generation e-cigarette device will be used with pre-determined temperature, voltage and wattage settings, and pre-mixed e-solution containing nicotine.
- OTHER
-
E-cigarette vapor, nicotine free
A fourth generation e-cigarette device will be used with pre-determined temperature, voltage and wattage settings, and pre-mixed nicotine free e-solution.
Sponsors & Collaborators
- collaborator OTHER
-
Umeå University
lead OTHER
Principal Investigators
-
Jenny A Bosson, MD;PhD · Umeå University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-04-01
- Primary Completion
- 2019-05-29
- Completion
- 2019-06-10
Countries
- Sweden
Study Locations
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