RecruitingEarly Phase 1NCT06159608

Sex Differences in the Vascular Effects of E-cigarette Use


Sponsor

Anna Stanhewicz, PhD

Enrollment

80 participants

Start Date

Dec 2, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 24 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how e-cigarette use (vaping) affects blood vessel function in young adults aged 18 to 24, and whether there are differences between males and females in these effects. Researchers are particularly interested in the microvascular (small blood vessel) changes associated with vaping, using minimally invasive skin tests with localized drug delivery and heat to explore how blood vessels respond. Healthy young adults who are either non-users of e-cigarettes or have been using e-cigarettes consistently for at least 6 months are eligible, while those with cardiovascular or metabolic diseases, BMI over 30, current or past tobacco use, or blood pressure of 140/90 or higher are excluded. Participation involves a single lab visit where small dialysis probes are placed under the skin of the forearm, blood and urine samples are taken, and blood vessel responses are measured with and without local heating. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLocal heating + L-NAME (NG-nitro-L-arginine methyl ester; nitric oxide synthase inhibitor)

Differences in endothelium- and nitric oxide (NO)-dependent dilation between groups

OTHERChronic estrogen exposure

differences in urine estrogen levels across the menstrual cycle between women groups only


Locations(1)

University of Iowa

Iowa City, Iowa, United States

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NCT06159608


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