Clinical trial NCT06474962: Cardiorespiratory Fitness and Health Parameters in E-cigarrete Users: Impact of a Short Term Pause in Consumption
Official title: Cardiorespiratory Fitness and Health Parameters in E-cigarrete Users: Impact of a Short Term Pause in Consumption
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Electronic Nicotine Delivery Systems
Keywords: vaping
e-cigarette
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 148
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Goal: Investigate the health effects of electronic cigarettes (e-cigarettes) and whether a short break from using them can improve health.

Participants:

Up to 148 people (74 who use e-cigarettes and 74 who don't) Age and sex will be matched between the groups.

Study Design:

Two connected studies:

Observational Study: Compares general health (including lung function, heart health, blood pressure, and inflammation) of e-cigarette users to non-smokers.

Clinical Trial: E-cigarette users will be randomly assigned to either:

Take a 7-day break from e-cigarettes (intervention group) Continue using e-cigarettes as usual (control group) Both groups will have their health measured before and after the 7-day period. Main Outcome: How well your heart and lungs work during exercise.

Other Outcomes: Lung function, blood vessel function, risk factors for heart disease, and body measurements.

Why is this study important?

E-cigarettes are becoming more popular, but their health effects are unknown. This study will provide new information on whether e-cigarettes harm your health and if quitting for a short time can improve it.

This information can be used to create better public health policies about e-cigarettes.

Detailed description: The emergence of electronic smoking devices is a recent and scientifically underexplored phenomenon. These devices were initially thought of as a harm-reduction strategy in cigarette smokers, a purpose for which there is still no definitive evidence of effectiveness. Preliminary but consistent findings in the literature suggest the possibility of detrimental health effects to e-cigarette users. Despite being prohibited for sale in the country, electronic cigarettes are easily accessible, in an unregulated manner. The increasing number of users, approaching one million according to recent data, and the uncertainties regarding the composition, manufacturing quality, and potential long-term effects of exposure to the vapor they produce, make the use of electronic cigarettes an emerging issue in Brazilian public health. Based on the aforementioned issues, exploring the potential effects of this new health-related behavior is urgent. Thus, the present proposal describes a research project envisioning the execution of two interconnected studies: (1) an observational cross-sectional analysis, in an exposed-control design, evaluating general health parameters of electronic cigarette users compared to non-smoking control individuals, matched by sex and age; and (2) an intervention study nested within the first study, designed as a randomized clinical trial, with electronic cigarette users assigned to a group that will take a 7-day pause from using these devices, compared to a control group that will not undergo any intervention. The studies were designed with cardiorespiratory fitness - measured by a maximum exercise cardiopulmonary test (ergospirometry) - as the primary outcome. The sample size calculated for the cross-sectional study comprises 148 individuals (74 per group), and the intended sample for the randomized clinical trial consists of the 74 electronic cigarette users already recruited for the cross-sectional study. The secondary outcomes of both studies are related to cardiorespiratory parameters, pulmonary function (spirometry), vascular function (endothelial function and tissue oxygenation), cardiovascular risk (lipid profile and blood pressure), inflammatory markers, and anthropometric measurements. The statistical analyses will be performed using Analysis of Covariance (ANCOVA), with physical activity level as a covariate for the cross-sectional study, and Generalized Estimating Equations (GEE), with initial oxygen consumption value as a covariate for the clinical trial. The investigators expect that the proposed studies yield new and relevant information regarding the potential harmful effects of electronic cigarettes, as well as the possibility of reversing these effects through refraining from their consumption. The novelty of the studies, the urgency of the topic, the boldness of the experimental approaches, and the high immediate applicability of the findings are highlighted in this proposal, with the potential to support public health policies concerning this relevant issue.

Eligibility criteria: Inclusion Criteria:

* 14 years of age or older
* Reporting using nicotine electronic cigarettes (e-cigarettes)
* Serum cotinine levels equal to or greater than 3 ng/mL

Exclusion Criteria:

* Contraindications for maximum exercise testing or any of study procedures
* Use of any smoking product except e-cigarette (combustible cigarette, cigar, hookah, marijuana, etc.)

Primary outcomes:
measure: Maximal oxygen consumption
timeFrame: Baseline
measure: Maximal oxygen consumption
timeFrame: 7 days
Secondary outcomes:
measure: Pulmonary function
timeFrame: Baseline
measure: Pulmonary function
timeFrame: 7 days
measure: Endothelial function
timeFrame: Baseline
measure: Endothelial function
timeFrame: 7 days
measure: Lipid profile
timeFrame: Baseline
measure: Lipid profile
timeFrame: 7 days
measure: Health-related quality of life
timeFrame: Baseline
measure: Health-related quality of life
timeFrame: 7 days
measure: Anxiety symptoms
timeFrame: Baseline
measure: Anxiety symptoms
timeFrame: 7 days
measure: Blood pressure
timeFrame: Baseline
measure: Inflammatory status
timeFrame: Baseline
measure: Inflammatory status
timeFrame: 7 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Clinical Hospital of the School of Medicine, University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Bruno Gualano, PhD
role: PRINCIPAL_INVESTIGATOR
References: