Sex Differences in the Vascular Effects of E-cigarette Use

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Anna Stanhewicz, PhD
Study ID
NCT06159608
Phase
EARLY_PHASE1
Status
Recruiting

Conditions

  • E-cigarette Use

Eligibility Criteria

Sex
ALL
Age
18 Years - 24 Years
Healthy Volunteers
Accepted

Interventions

  • Local heating + L-NAME (NG-nitro-L-arginine methyl ester; nitric oxide synthase inhibitor) — DRUG
    Differences in endothelium- and nitric oxide (NO)-dependent dilation between groups
  • Chronic estrogen exposure — OTHER
    differences in urine estrogen levels across the menstrual cycle between women groups only

Study Details

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.

Key Dates

Start date
Dec 2, 2023
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Healthy Young Women
    Young women who do not use e-cigarettes
  • Other: Healthy Young Men
    Young men who do not use e-cigarettes
  • Other: Young Women using E-cigarettes
    Young women chronically use e-cigarettes
  • Other: Young Men using E-cigarettes
    Young men chronically use e-cigarettes

Primary Outcome Measure

Change in microvascular endothelium-dependent dilation response measured by laser-Doppler flowmetry [ Time Frame: at the study visit, an average of 4 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242
Anna Stanhewicz
319-467-1732

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