About this trial
The use of electronic nicotine delivery systems, or e-cigarettes - colloquially referred to as "vaping" - in the United States has increased exponentially since their introduction to the US market in 2007. Prevalence of ever and current e-cigarette use is highest among teenagers and young adults with 16-28% of this population having reported vaping. While the majority of e-cigarette users are current tobacco smokers, 32.5% of current e-cigarette users are never- or former-smokers, representing a growing population of young adults who exclusively vape. While e-cigarettes have been marketed as a safer alternative to tobacco cigarettes, clinical studies examining these claims are limited. Cardiovascular disease (CVD) is the primary cause of premature death among tobacco cigarette smokers and reductions in vascular endothelial function, a significant predictor of future CVD, are detectible in otherwise healthy young adults who smoke. Despite the explosion in e-cigarette use among young adults, the health effects - especially the effects on mechanisms of vascular function - of these devices remain relatively unexplored.
In this study, we use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) we examine the blood vessels in a dime-sized area of the skin in otherwise healthy young (18-24yrs) chronic e-cigarette users. Local heating of the skin at the microdialysis sites is used to explore differences in mechanisms governing microvascular control. As a compliment to these measurements, we also draw blood from the subjects to measure circulating factors that may contribute to cardiovascular health and examine markers of inflammatory activation. We will also collect urine from female participants to measure estradiol.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18-24 years old
have no history of e-cigarette use
be a current e-cigarette user who has been using e-cigarettes for 6 months or longer
Disqualifiers
history of cardiovascular, metabolic, and/or skin diseases
body mass index >30 kg/m2
blood pressure ≥140 systolic and/or ≥ 90 diastolic
current or history of tobacco cigarette use
Trial design
Parallel
Treatments tested in this trial
Local heating + L-NAME (NG-nitro-L-arginine methyl ester; nitric oxide synthase inhibitor)
DrugDifferences in endothelium- and nitric oxide (NO)-dependent dilation between groups
Chronic estrogen exposure
Other interventiondifferences in urine estrogen levels across the menstrual cycle between women groups only
Treatment groups
Trial outcomes
Primary outcomes
Change in microvascular endothelium-dependent dilation response measured by laser-Doppler flowmetry
cutaneous vascular vasodilator responses to local heating over a microdialysis fiber receiving lactated Ringer's solution, followed by L-NAME infusion to quantify NO-dependent response
monthly estrogen exposure
daily estradiol levels will be measured in all women for 1 month/menstrual cycle
Sponsors and contacts
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Anna Stanhewicz, PhD
Lead sponsor
University of Iowa
Sponsor institution