Acute Effects of E-Cigarette Aerosol Inhalation

Early Phase 1CompletedNCT03479203

University of Pennsylvania31 enrolled

Overview

This study comprises a portion of a larger study designed to compare results of vascular function in non-smokers to vascular function in healthy smokers chronically exposed to nicotinized electronic cigarette aerosol versus conventional cigarettes.

Here, we 1) investigate the acute effects of non-nicotinized e-cigarette aerosol inhalation in nonsmokers in terms of blood-based markers of inflammation and oxidative stress, and 2) evaluate their association with hemodynamic-metabolic MRI parameters quantifying peripheral vascular reactivity, cerebrovascular reactivity, and aortic stiffness.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Endothelial Dysfunction Biochemical Markers

Interventions

Electronic Cigarette AerosolDRUG

16 two-second-long puffs from a non-nicotinized electronic cigarette.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: • BMI of 18.5 - 30 Exclusion Criteria: * Cancer * HIV * Mental illness * Overt cardio- or neurovascular disease (prior heart attack, stroke, transient ischemic attacks) * Serious arrhythmias * Bronchospastic disease * Upper respiratory tract infection within the past six weeks * Chronic medication or antibiotics * Claustrophobia / contraindications for MRI

Locations (1)

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Inflammatory Blood-Based Biomarkers

Post-vaping inflammation monitored by changes in an integrated cluster of blood-based biomarkers from serum/plasma of non-smoking healthy participants quantified at 0 and 120 min post-inhalation. The cluster consisted of: CRP, sICAM-1 in serum and HMGB1, ASC in plasma assayed using ELISA and quantified using absorbance-concentration curves generated by the manufacturers' standards; nitric oxide metabolites (nitrate + nitrite, NOx) in serum assayed with a nitrate/nitrite kit using a colorimetric standard provided by the manufacturer; reactive oxygen species (ROS) was quantified by using immortalized human pulmonary microvascular endothelial cells plated, prepared with serum, labeled with ROS dye and imaged confocal fluorescence microscopy. The outcome measure was expressed as fold increase over pre-vaping values.

Time frame: Participant blood draws occurred at two time points: 1) pre-vaping, 2) 120 minutes post-vaping. Inflammation index is calculated from the fold change in biomarker values over pre-vaping values

Acute Change in Aortic Pulse Wave Velocity Post-vaping

Central arterial stiffness was assessed using aortic pulse-wave velocity (PWV), a biomarker of aortic stiffness calculated by measuring the velocity of a pulse wave between two points in the same artery. A higher aortic pulse wave velocity equates to a stiffer aorta. In each participant, aortic PWV was quantified, pre- and post-vaping, by dividing the path length of the aortic arch determined from a oblique sagittal image, by the transit time of the pulse pressure wave. Measurements obtained pre-vaping were compared to those obtained post-vaping.

Time frame: PWV calculation occurred at two time points: 1) pre-vaping, 2) Fifteen minutes post-vaping.

Change in Femoral Artery Flow-Mediated Dilation Post-Vaping

Degree of dilation (% change in cross-sectional area) of femoral artery during hyperemia (the transient increase in blood flow velocity) after e-cigarette vaping as compared to before e-cigarette vaping.

Time frame: Flow mediated dilation calculation occurred at two time points: 1) pre-vaping, 2) 40 minutes post-vaping.

Change in Washout Time Post-Vaping

Data from ClinicalTrials.gov

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