Clinical trial NCT06489249: Role of Inflammation in Vascular Phenotype Associated with E-cigarette Use
Official title: Role of Inflammation in Vascular Phenotype Associated with E-cigarette Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Electronic Cigarette Use
Endothelial Dysfunction
Inflammation
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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. The purpose of this study is to directly asses the mechanistic role of inflammation in this dysfunction.


Eligibility criteria: Inclusion Criteria:

* 18 - 24 years of age
* no history of e-cigarette use (control) OR current with 6 months or more history of e-cigarette use (chronic use).

Exclusion Criteria:

* tobacco cigarette use (current or history of)
* use of stimulant drugs
* skin diseases
* cardiovascular disease
* diagnosed or suspected hepatic or metabolic disease including diabetes
* statin or other cholesterol-lowering medication
* antihypertensive medication
* current pregnancy or breastfeeding
* blood pressure greater than or equal to 140mmHg systolic and/or greater than or equal to 90mmHg diastolic
* allergy to materials used during the experiment
* known allergies to salsalate or other study drugs

Primary outcomes:
measure: Microvascular endothelial function (Cutaneous conductance, %maximum) following salsalate treatment compared to placebo treatment
timeFrame: a total of 2 times throughout the study (approximately 4 weeks): 1) at the completion of 4 days of oral salsalate treatment, and 2) at the completion of 4 days of placebo treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Iowa Bioscience Innovation Facility
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
References: