E-cigarettes and Blood Vessel Function

October 2, 2023 updated by: Holly R Middlekauff, University of California, Los Angeles

The Effects of Electronic Cigarettes on Endothelial Function and Oxidative Stress

Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and sham control, on endothelial function and markers of oxidative stress.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will use an electronic cigarette on 3 occasions: 1) with nicotine, 2) without nicotine, 3) sham control, and undergo a measure of endothelial function called brachial artery flow mediated dilatation (FMD). Additionally, oxidative stress will be measured pre and post exposure.

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCaliforniaLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Cardiac disease
  • Respiratory disease
  • Diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nicotine
Use an e-cig filled with liquid with nicotine
Other: one time exposure to e-cig with nicotine
one time exposure to e-cig vapor with nicotine
Experimental: no nicotine
Use an e-cig filled with liquid without nicotine
Other: one time exposure to e-cig without nicotine
one time exposure to e-cig without nicotine
Sham Comparator: sham comparator
Use an empty e-cigarette (sham control)
Other: one time exposure to empty e-cig
one time exposure to empty e-cig (sham control
Other Names:
  • sham control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow mediated dilatation (FMD)
Time Frame: 10 minutes after exposure
FMD is a measure of endothelial function
10 minutes after exposure
Paraoxonse
Time Frame: less than 1 hour after exposure
plasma oxidative stress
less than 1 hour after exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (Estimated)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-000743

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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