Sex Differences in the Vascular Effects of E-cigarette Use

NCT ID: NCT06159608

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-02
• Study Completion Date: 2025-11-30

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.

Conditions

E-cigarette Use

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy Young Women

Young women who do not use e-cigarettes

Group Type: OTHER

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

Intervention Type: DRUG

Differences in endothelium- and nitric oxide (NO)-dependent dilation between groups

Chronic estrogen exposure

Intervention Type: OTHER

differences in urine estrogen levels across the menstrual cycle between women groups only

Healthy Young Men

Young men who do not use e-cigarettes

Group Type: OTHER

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

Intervention Type: DRUG

Differences in endothelium- and nitric oxide (NO)-dependent dilation between groups

Young Women using E-cigarettes

Young women chronically use e-cigarettes

Group Type: OTHER

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

Intervention Type: DRUG

Differences in endothelium- and nitric oxide (NO)-dependent dilation between groups

Chronic estrogen exposure

Intervention Type: OTHER

differences in urine estrogen levels across the menstrual cycle between women groups only

Young Men using E-cigarettes

Young men chronically use e-cigarettes

Group Type: OTHER

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

Intervention Type: DRUG

Differences in endothelium- and nitric oxide (NO)-dependent dilation between groups

Interventions

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

Intervention Type: DRUG

Chronic estrogen exposure

differences in urine estrogen levels across the menstrual cycle between women groups only

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Anna Stanhewicz, PhD

OTHER

Sponsor Role: lead

Responsible Party

Anna Stanhewicz, PhD

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Iowa

Iowa City, Iowa, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anna Reid-Stanhewicz, PHD

Role: CONTACT

Phone: 319-467-1732

Email: anna-stanhewicz@uiowa.edu

Facility Contacts

Anna Stanhewicz

Role: primary

Other Identifiers

202308025

Identifier Type: -

Identifier Source: org_study_id