Electronic Hookah and Endothelial Cell Function

Not Applicable

Completed

• Conditions: Smoking; Endothelial Dysfunction
• Interventions: Other: Electronic hookah vaping with nicotine; Other: Electronic hookah vaping without nicotine

• Registration Number: NCT04133376
• Lead Sponsor: University of California, Los Angeles

Brief Summary

Electronic nicotine delivery systems (ENDS) are a rapidly growing global epidemic among adolescents and young adults. Unlike other ENDS such as e-cigarettes, e-hookahs are used through traditional water-pipes, allowing the vapor-containing nicotine, propylene glycol, glycerin, and flavorings-to pass through a water-filled basin, potentially altering the vapor, before it is inhaled through the user's mouth. Contributing to e-hookahs popularity is the belief that the flavored smoke is detoxified as it passes through the water-filled basin, rendering e-hookah a safer tobacco alternative. However, an e-hookahs deliver flavored nicotine by creating a vapor of fine particles and volatile organic compounds that could induce vascular toxicity. While e-hookah vaping acutely reduces endothelial function, the specific role of nicotine and the mechanisms by which it may impairs endothelial function remain understudied. The objective of this project is to investigate the specific role of nicotine in mediating the acute effects of e-hookah vaping on endothelial dysfunction.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-17
• Study First Posted: 2019-10-21
• Study Start: 2019-11-01
• Primary Completion: 2023-05-29
• Study Completion: 2023-05-29
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

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Exclusion Criteria

• exhaled CO>10 ppm (smoking non-abstinence)
• positive pregnancy test
• psychiatric illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
e-hookah vaping with nicotine	Electronic hookah vaping without 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.
e-hookah vaping without nicotine	Electronic 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.
e-hookah vaping without nicotine	Electronic hookah vaping with 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.
e-hookah vaping with nicotine	Electronic 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.

Primary Outcome Measures

Name	Time	Method
Basal reactive oxygen species bioactivity	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
Nicotine levels	Changes pre- and post- the 30-minute smoking or vaping exposure sessions	Plasma nicotine
Heme oxygenase-1 assay	Changes pre- and post- the 30-minute smoking or vaping exposure sessions	Heme oxygenase-1 concentration assay
paraoxonase-1 activity	Changes pre- and post- the 30-minute smoking or vaping exposure sessions	paraoxonase-1 activity
Carbon monoxide levels	Changes pre- and post- the 30-minute smoking or vaping exposure sessions	Exhaled carbon monoxide levels
Flow-Mediated Dilation (FMD)	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.
Acetylcholine-stimulated nitric oxide production	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
Fibrinogen levels	Changes pre- and post- the 30-minute smoking or vaping exposure sessions	Plasma fibrinogen
HDL protection assay	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

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States