Back to resultsECigs, Inflammation and Oxidative Stress
Primary Purpose
E-cigarettes, Oxidative Stress, Inflammation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
e-cigarette
empty (-cigarette sham control)
Sponsored by
About this trial
This is an interventional basic science trial for E-cigarettes, Oxidative Stress, Inflammation
Eligibility Criteria
Inclusion Criteria:
- Healthy
Exclusion Criteria:
- Cardiac disease Respiratory disease Diabetes
Sites / Locations
- UCLA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
E-cig
sham
Arm Description
One time exposure to e-cig
One time exposure to empty e-cig
Outcomes
Primary Outcome Measures
Cellular Reactive Oxygen Species, units = % fluorescence
cellular oxidative stress, including cytoplasmic and mitochondrial oxidative stress, in viable cells
Secondary Outcome Measures
CD 14+ Monocyte, units = % of total cells
CD 14+ Monocyte, % of total cells will be measured with antibodies and stable dye
Full Information
NCT ID
NCT03823885
First Posted
January 24, 2019
Last Updated
October 2, 2023
Sponsor
University of California, Los Angeles
Collaborators
Tobacco Related Disease Research Program
1. Study Identification
Unique Protocol Identification Number
NCT03823885
Brief Title
ECigs, Inflammation and Oxidative Stress
Official Title
E-Cigarettes and Monocytes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 8, 2019 (Actual)
Primary Completion Date
February 8, 2023 (Actual)
Study Completion Date
October 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Tobacco Related Disease Research Program
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized controlled trial of acute use of electronic cigarette effect on oxidative stress and inflammation.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
E-cigarettes, Oxidative Stress, Inflammation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover with 2 week washout
Masking
Outcomes Assessor
Masking Description
Code
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
E-cig
Arm Type
Experimental
Arm Description
One time exposure to e-cig
Arm Title
sham
Arm Type
Experimental
Arm Description
One time exposure to empty e-cig
Intervention Type
Other
Intervention Name(s)
e-cigarette
Other Intervention Name(s)
e-cig
Intervention Description
use e-cig for 30 minutes
Intervention Type
Other
Intervention Name(s)
empty (-cigarette sham control)
Other Intervention Name(s)
empty e-cig
Intervention Description
use empty e-cig (sham control)
Primary Outcome Measure Information:
Title
Cellular Reactive Oxygen Species, units = % fluorescence
Description
cellular oxidative stress, including cytoplasmic and mitochondrial oxidative stress, in viable cells
Time Frame
within 4 hours of E-cig use
Secondary Outcome Measure Information:
Title
CD 14+ Monocyte, units = % of total cells
Description
CD 14+ Monocyte, % of total cells will be measured with antibodies and stable dye
Time Frame
within 4 hours of e-cig use
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy
Exclusion Criteria:
Cardiac disease Respiratory disease Diabetes
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32896211
Citation
Kelesidis T, Tran E, Arastoo S, Lakhani K, Heymans R, Gornbein J, Middlekauff HR. Elevated Cellular Oxidative Stress in Circulating Immune Cells in Otherwise Healthy Young People Who Use Electronic Cigarettes in a Cross-Sectional Single-Center Study: Implications for Future Cardiovascular Risk. J Am Heart Assoc. 2020 Sep 15;9(18):e016983. doi: 10.1161/JAHA.120.016983. Epub 2020 Sep 8.
Results Reference
derived
Learn more about this trial
ECigs, Inflammation and Oxidative Stress
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