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E-cigarettes and Blood Vessel Function

Sponsor
University of California, Los Angeles (Other)
Overall Status
Recruiting
CT.gov ID
NCT02740595
Collaborator
(none)
120
Enrollment
1
Location
3
Arms
88
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: one time exposure to e-cig with nicotine
  • Other: one time exposure to e-cig without nicotine
  • Other: one time exposure to empty e-cig
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Effects of Electronic Cigarettes on Endothelial Function and Oxidative Stress
Study Start Date :
Aug 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Flow mediated dilatation (FMD) [10 minutes after exposure]

      FMD is a measure of endothelial function

    2. Paraoxonse [less than 1 hour after exposure]

      plasma oxidative stress

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Healthy
    Exclusion Criteria:

    • Cardiac disease

    • Respiratory disease

    • Diabetes mellitus

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCaliforniaLA Los Angeles California United States 90095

    Sponsors and Collaborators

    • University of California, Los Angeles

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Holly R Middlekauff, Professor of Medicine, University of California, Los Angeles
    ClinicalTrials.gov Identifier:
    NCT02740595
    Other Study ID Numbers:
    • 14-000743
    First Posted:
    Apr 15, 2016
    Last Update Posted:
    Mar 17, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Holly R Middlekauff, Professor of Medicine, University of California, Los Angeles
    nicotine
    endothelial function
    oxidative stress
    Additional relevant MeSH terms:
    Tobacco Use Disorder
    Nicotine

    Study Results

    No Results Posted as of Mar 17, 2020