- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04133376
Electronic Hookah and Endothelial Cell Function
The Effects of Electronic Hookah on Endothelial Cell Function: The Role of Nicotine
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90024
- University of California, Los Angeles
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 21-39 years old hookah smokers: smoked hookah >12x in last 12 months
- 21-39 years old e-cigarette users: vaped >12x in last 12 months
- no history of illicit drugs
- no evidence of cardiopulmonary disease by history/ physical
- no diabetes: fasting blood glucose <100 mg/dl
- BP<140/90mmHg
- resting HR<100 bpm
- BMI<30kg•m2
- no prescription medication
Exclusion Criteria:
- exhaled CO>10 ppm (smoking non-abstinence)
- positive pregnancy test
- psychiatric illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: e-hookah vaping with nicotine
Participants were invited to vape a 30-minute electronic hookah with nicotine vaping session, followed by a 30-minute electronic hookah without nicotine vaping session. To mitigate the impact of carryover effects, the two sessions were separated by a minimum of 7-days. |
Participants will be invited to vape a 30-minute session of e-hookah containing nicotine
Participants will be invited to vape a 30-minute session of e-hookah without containing nicotine
|
|
Experimental: e-hookah vaping without nicotine
Participants were invited to vape a 30-minute electronic hookah without nicotine vaping session, followed by a 30-minute electronic hookah with nicotine vaping session. To mitigate the impact of carryover effects, the two sessions were separated by a minimum of 7-days. |
Participants will be invited to vape a 30-minute session of e-hookah containing nicotine
Participants will be invited to vape a 30-minute session of e-hookah without containing nicotine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Flow-Mediated Dilation (FMD)
Time Frame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions
|
Using ultrasound, FMD of the brachial artery induced by reactive hyperemia, was used to measure endothelium-dependent vasodilator function.
Outcome variable reflecting FMD (brachial artery diameter) was recorded for 45 seconds and resumed 30 seconds before cuff deflation and continuously for 2 minutes after deflation to obtain true peak vasodilatory response.
|
Changes pre- and post- the 30-minute smoking or vaping exposure sessions
|
|
Acetylcholine-stimulated nitric oxide production
Time Frame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions
|
Human umbilical vein endothelial cells were cultured with subjects' serum sampled before and after the vaping sessions and acetylcholine-stimulated nitric oxide production was assessed
|
Changes pre- and post- the 30-minute smoking or vaping exposure sessions
|
|
Basal reactive oxygen species bioactivity
Time Frame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions
|
Human umbilical vein endothelial cells were cultured with participants' serum sampled before and after the vaping sessions and basal reactive oxygen species bioactivity was assessed
|
Changes pre- and post- the 30-minute smoking or vaping exposure sessions
|
|
Fibrinogen levels
Time Frame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions
|
Plasma fibrinogen
|
Changes pre- and post- the 30-minute smoking or vaping exposure sessions
|
|
Heme oxygenase-1 assay
Time Frame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions
|
Heme oxygenase-1 concentration assay
|
Changes pre- and post- the 30-minute smoking or vaping exposure sessions
|
|
paraoxonase-1 activity
Time Frame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions
|
paraoxonase-1 activity
|
Changes pre- and post- the 30-minute smoking or vaping exposure sessions
|
|
HDL protection assay
Time Frame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions
|
HDL protection assay, reflecting the ability of HDL to inhibit oxidation to LDL
|
Changes pre- and post- the 30-minute smoking or vaping exposure sessions
|
|
Nicotine levels
Time Frame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions
|
Plasma nicotine
|
Changes pre- and post- the 30-minute smoking or vaping exposure sessions
|
|
Carbon monoxide levels
Time Frame: Changes pre- and post- the 30-minute smoking or vaping exposure sessions
|
Exhaled carbon monoxide levels
|
Changes pre- and post- the 30-minute smoking or vaping exposure sessions
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mary Rezk-Hanna, PhD, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T30IP1013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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