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Sex Differences in the Vascular Effects of E-cigarette Use

Sex Differences in the Vascular Effects of E-cigarette Use

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06159608
Enrollment
80
Registered
2023-12-07
Start date
2023-12-02
Completion date
2026-12-31
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E-cigarette Use

Brief 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.

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

Sponsors

Anna Stanhewicz, PhD
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes

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 or longer

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-cigarettes in the past

Design outcomes

Primary

MeasureTime frameDescription
Change in microvascular endothelium-dependent dilation response measured by laser-Doppler flowmetryat the study visit, an average of 4 hourscutaneous 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 exposure1 monthdaily estradiol levels will be measured in all women for 1 month/menstrual cycle

Countries

United States

Contacts

Primary ContactAnna Reid-Stanhewicz, PHD
anna-stanhewicz@uiowa.edu319-467-1732

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026