Acute Vascular Effects of E-cigarette Use

NCT03746119 | Completed

• 1 other identifier: Umu-2019-31M
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Tobacco use harms nearly every organ in the body and has been linked to ischemic heart disease, chronic obstructive pulmonary disease, stroke, respiratory illness, lung cancer and other cancers. The World Health Organization estimates that 6 million people worldwide lose their lives due to tobacco use yearly, making cigarette smoking one of the leading single causes of preventable death and morbidity. As this knowledge becomes more common and wide-spread the sales of cigarettes has seen a decrease in recent years. On account of this, the electronic cigarette (e-cigarette) has been introduced to the market as an alternative to traditional cigarette smoking. Electronic cigarettes, also known as e-cigarettes or e-cigs, are delivery devices which heat a base liquid, to which nicotine and flavorings can be added, into vapor which is then inhaled ("vaping"). E-cigarettes have been aggressively marketed as a cheaper, healthier, cleaner alternative to smoking in both advertising and media outlets, primarily targeting adolescents. Despite growing e-cigarette use, scientific data on health effects are insufficient in some respects and completely lacking in others. However, the investigators have recently shown that cigarette smoking, as well as e-cigarette inhalation, both cause an acute increase of endothelial progenitor cells (EPCs) in the blood of healthy volunteers, suggesting vascular injury, inflammation and a negative impact on hemostasis. Therefore, using well validated methods, including forearm plethysmography, biomarkers in blood, arterial stiffness measurements and microcirculation assessment (GlycoCheck), the investigators aim to further investigate the effects of e-cigarette inhalation on the vascular system. These measurements will be performed before and after healthy subjects inhale vapor from a e-cigarette on two separate occasions, with and without nicotine in a double-blinded, randomized protocol.

Conditions

Healthy

Keywords

Nicotine; Electronic cigarette; E-cigarrette; Forearm Plethysmography

Outcome Measures

Primary Outcomes (1)

• Vascular vasomotor function

  Forearm venous occlusion plethysmography to measure forearm blood flow during unilateral intrabrachial infusion of endothelial-dependent and -independent vasodilators. Assessment is shown in ml/100ml tissue/min.

  3 hours

Secondary Outcomes (4)

• Arterial Stiffness

  1 hour

• Arterial Stiffness

  1 hour

• Cotinine Cardiovascular biomarkers Cardiovascular biomarkers

  6 hours

• Microcirculation assessment

  1 hour

Study Arms (2)

Nicotine-free e-cigarette

ACTIVE COMPARATOR

Subjects will undergo baseline assessments, then actively inhale nicotine-free vapor from an e-cigarette prior to blood samples and various cardiovascular testing.

Other: E-cigarette vapor, nicotine free

Nicotine e-cigarette

ACTIVE COMPARATOR

Subjects will undergo baseline assessments, then actively inhale nicotine containing vapor from an e-cigarette prior to blood samples and various cardiovascular testing.

Other: E-cigarette vapor containing nicotine

Interventions

E-cigarette vapor containing nicotine OTHER

A fourth generation e-cigarette device will be used with pre-determined temperature, voltage and wattage settings, and pre-mixed e-solution containing nicotine.

Nicotine e-cigarette

E-cigarette vapor, nicotine free OTHER

A fourth generation e-cigarette device will be used with pre-determined temperature, voltage and wattage settings, and pre-mixed nicotine free e-solution.

Nicotine-free e-cigarette

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Intermittent/sporadic use of forms of nicotine
• Normal clinical examination
• Normal EKG
• Normal blood tests
• Normal lung function

You may not qualify if:

• Diagnosed cardiovascular disease
• Diagnosed respiratory disease
• Diagnosed systemic or chronic disorders such as rheumatologic or metabolic disease
• Symptoms of infection or inflammation within 2 weeks of the study
• BMI≥30

Sponsors & Collaborators

• Umeå University: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Umeå University

Umeå, 90185, Sweden

Location

MeSH Terms

Conditions

Vaping

Interventions

E-Cigarette Vapor

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Aerosols; Colloids; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Jenny A Bosson, MD;PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; PhD

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 19, 2018
• Study Start: April 1, 2019
• Primary Completion: May 29, 2019
• Study Completion: June 10, 2019
• Last Updated: September 30, 2019

Record last verified: 2019-09

Locations

SE (1)