ECigs, Inflammation and Oxidative Stress

NCT ID: NCT03823885

Last Updated: 2023-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-08

Study Completion Date

2023-10-01

Brief Summary

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

Detailed Description

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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.

Conditions

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E-cigarettes, Oxidative Stress, Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover with 2 week washout
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors
Code

Study Groups

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E-cig

One time exposure to e-cig

Group Type EXPERIMENTAL

e-cigarette

Intervention Type OTHER

use e-cig for 30 minutes

sham

One time exposure to empty e-cig

Group Type EXPERIMENTAL

empty (-cigarette sham control)

Intervention Type OTHER

use empty e-cig (sham control)

Interventions

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e-cigarette

use e-cig for 30 minutes

Intervention Type OTHER

empty (-cigarette sham control)

use empty e-cig (sham control)

Intervention Type OTHER

Other Intervention Names

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e-cig empty e-cig

Eligibility Criteria

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Inclusion Criteria

* Healthy

Exclusion Criteria

* Cardiac disease Respiratory disease Diabetes
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tobacco Related Disease Research Program

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Holly R Middlekauff

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UCLA

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32896211 (View on PubMed)

Other Identifiers

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18001147

Identifier Type: -

Identifier Source: org_study_id

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