Sex Differences in the Vascular Effects of E-cigarette Use
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Local heating + L-NAME (NG-nitro-L-arginine methyl ester; nitric oxide synthase inhibitor), Chronic estrogen exposure.
- Who it may be relevant to
- Registry conditions: E-cigarette Use. Basic parameters: 18 years — 24 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Local heating + L-NAME (NG-nitro-L-arginine methyl ester; nitric oxide synthase inhibitor)
Differences in endothelium- and nitric oxide (NO)-dependent dilation between groups - Other Chronic estrogen exposure
differences in urine estrogen levels across the menstrual cycle between women groups only
Primary outcome measures
- Change in microvascular endothelium-dependent dilation response measured by laser-Doppler flowmetry [Time frame: at the study visit, an average of 4 hours]
- monthly estrogen exposure [Time frame: 1 month]
Eligibility criteria
Inclusion criteria
- 18-24 years old
- one of the following:
- have no history of e-cigarette use
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Iowa — Iowa City
Identifiers
NCT: NCT06159608 · 202308025