Electronic Hookah and Endothelial Cell Function

Smoking Clinical Trial

Official title:

The Effects of Electronic Hookah on Endothelial Cell Function: The Role of Nicotine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04133376
• Other study ID #: T30IP1013
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: May 29, 2023

Study information

• Verified date: November 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 29, 2023
• Est. primary completion date: May 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Smoking

Intervention

Other:
• Electronic hookah vaping with nicotine
Participants will be invited to vape a 30-minute session of e-hookah containing nicotine
• Electronic hookah vaping without nicotine
Participants will be invited to vape a 30-minute session of e-hookah without containing nicotine

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Tobacco Related Disease Research Program

Country where clinical trial is conducted

United States, 

Outcome

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