Clinical trial NCT06159608: Sex Differences in the Vascular Effects of E-cigarette Use
Official title: Sex Differences in the Vascular Effects of E-cigarette Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: E-cigarette Use
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in microvascular endothelium-dependent dilation response measured by laser-Doppler flowmetry
timeFrame: at the study visit, an average of 4 hours
measure: monthly estrogen exposure
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
References: