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ECigs, Inflammation and Oxidative Stress

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ClinicalTrials.gov Identifier: NCT03823885
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : December 7, 2021
Sponsor:
Collaborator:
Tobacco Related Disease Research Program
Information provided by (Responsible Party):
Holly R Middlekauff, University of California, Los Angeles

Brief Summary:
Randomized controlled trial of acute use of electronic cigarette effect on oxidative stress and inflammation.

Condition or disease Intervention/treatment Phase
E-cigarettes, Oxidative Stress, Inflammation Other: e-cigarette Other: empty (-cigarette sham control) Not Applicable

Detailed Description:
Participants will have an acute e-cig exposure on 2 occasions 1) e-cigarette 2) sham e-cig (empty e-cig) control. Blood will be collected before and after E-cig use and analyzed for biomarkers of inflammation and oxidative stress.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover with 2 week washout
Masking: Single (Outcomes Assessor)
Masking Description: Code
Primary Purpose: Basic Science
Official Title: E-Cigarettes and Monocytes
Actual Study Start Date : February 8, 2019
Estimated Primary Completion Date : February 8, 2022
Estimated Study Completion Date : February 8, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: E-cig
One time exposure to e-cig
Other: e-cigarette
use e-cig for 30 minutes
Other Name: e-cig

Experimental: sham
One time exposure to empty e-cig
Other: empty (-cigarette sham control)
use empty e-cig (sham control)
Other Name: empty e-cig




Primary Outcome Measures :
  1. Cellular Reactive Oxygen Species, units = % fluorescence [ Time Frame: within 4 hours of E-cig use ]
    cellular oxidative stress, including cytoplasmic and mitochondrial oxidative stress, in viable cells


Secondary Outcome Measures :
  1. CD 14+ Monocyte, units = % of total cells [ Time Frame: within 4 hours of e-cig use ]
    CD 14+ Monocyte, % of total cells will be measured with antibodies and stable dye



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Cardiac disease Respiratory disease Diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823885


Contacts
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Contact: Holly R Middlekauff, MD 310-206-6672 hmiddlekauff@mednet.ucla.edu

Locations
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United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Karishma Lakhani, BA    310-825-3510    klakhani@mednet.ucla.edu   
Contact: Holly R Middlekauff, MD    310-206-6672    hmiddlekauff@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Tobacco Related Disease Research Program
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Holly R Middlekauff, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03823885    
Other Study ID Numbers: 18001147
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes