Sex Differences in the Vascular Effects of E-cigarette Use

E-cigarette Use Clinical Trial

Official title:

Sex Differences in the Vascular Effects of E-cigarette Use

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06159608
• Other study ID #: 202308025
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 2024
• Est. completion date: November 2025

Study information

• Verified date: December 2023
• Source: University of Iowa
• Contact: Anna Reid-Stanhewicz, PHD
• Phone: 319-467-1732
• Email: anna-stanhewicz[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• E-cigarette Use

Intervention

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

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Anna Stanhewicz, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in microvascular endothelium-dependent dilation response measured by laser-Doppler flowmetry	cutaneous 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	at the study visit, an average of 4 hours
Primary	monthly estrogen exposure	daily estradiol levels will be measured in all women for 1 month/menstrual cycle	1 month