Sex Differences in the Vascular Effects of E-cigarette Use

Last updated: December 19, 2024
Sponsor: Anna Stanhewicz, PhD
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Chronic estrogen exposure

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

Clinical Study ID

NCT06159608
202308025
  • Ages 18-24
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 18-24 years old

  • one of the following:

  1. have no history of e-cigarette use

  2. be a current e-cigarette user who has been using e-cigarettes for 6 months orlonger

Exclusion

Exclusion Criteria:

  • 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

  • current antihypertensive or cholesterol-lowering medication

  • current use of cannabis, marijuana, and/or other illegal substances

  • current use of stimulant drugs

  • currently pregnant or breastfeeding

  • allergy to materials used during the experiment (e.g. latex),

  • known allergy to study drugs

  • healthy control subjects will also be excluded if they have ever used e-cigarettesin the past

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Chronic estrogen exposure
Phase: 1
Study Start date:
December 02, 2023
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.