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临床试验/NCT03690427
NCT03690427已完成不适用

Investigating the Cardiovascular Toxicity of Exposure to Electronic Hookah Smoking

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2018年12月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
High-sensitivity C-reactive Protein (Hs-CRP) Levels

研究概览

简要总结

Hookah (water-pipe) tobacco smoking has quickly grown to become a major global tobacco epidemic among youth; with electronic (e-) hookahs more recently increasing in popularity especially among young female adults, who endorse marketing claims that these products are a safer alternative to traditional hookah, but scientific evidence is lacking. The study aims to elucidate the comparative effects of traditional hookah smoking vs. e-hookah vaping on human vascular and endothelial function; and examine the role of inflammation and oxidative stress, as likely mechanisms in hookah-related cardiovascular disease pathogenesis.

详细描述

Hookah (water-pipe) tobacco smoking is rapidly increasing in popularity worldwide. Contributing to this popularity is the unsubstantiated belief that traditional charcoal-heated hookah smoke is detoxified as it passes through the water-filled basin. More recently, electronic (e-) hookahs-containing flavored e-liquid that is heated electrically but inhaled through traditional water-pipes-are increasing in popularity in the United States among young female adults, who endorse marketing claims that these products are even safer than traditional charcoal-heated hookah products. The objective of this project is to investigate the comparative effects of traditional charcoal-heated hookah smoking versus e-hookah vaping on endothelial and vascular function and their mechanistic role in the development of cardiovascular disease. The investigators will test the hypothesis that: 1) in the absence of burning charcoal briquettes and virtually any carbon monoxide (CO) exposure, e-hookah vaping acutely impairs endothelial function and evokes acute central arterial stiffness, opposite from the endothelial function augmentation observed after traditional charcoal-heated hookah smoking, which is likely mediated by the large CO boost emitted from burning charcoal briquettes used to heat the flavored hookah tobacco; and 2) the processes of oxidative stress and inflammation play a pivotal mechanistic role underlying these vascular changes. Accordingly, in a cross-over study comparing traditional hookah smoking to e-hookah vaping, the investigators will assess endothelial function measured by brachial artery flow-mediated dilation and aortic stiffness by pulse wave velocity and augmentation index in 18 young healthy hookah smokers 21-39 years old, before and after ad lib 30-minute smoking/ vaping exposure sessions. To test for oxidative stress mediation, the investigators will determine if any acute impairment in endothelial function after e-hookah can be prevented by intravenous Vitamin C infusion, a potent anti-oxidant. Inflammatory and oxidant biomarkers, as well as smoking exposure biomarkers will be collected before and after the exposure sessions. The results of this proposal: (a) stand to fill in gaps in our mechanistic understanding of the comparative effect of traditional vs. e-hookah bowl on vascular and endothelial function; and (b) help inform policy decisions by the FDA about regulation of hookah products.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
21 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 21-39 years old hookah smokers: smoked hookah >12x in last 12 months
  • no history of illicit drugs or marijuana
  • 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

排除标准

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

结局指标

主要结局

High-sensitivity C-reactive Protein (Hs-CRP) Levels

时间窗: Pre- and post- the 30-minute smoking or vaping exposure sessions

Plasma hs-CRP (inflammatory biomarker)

HDL Oxidant Index (HOI)

时间窗: Pre- and post- the 30-minute smoking or vaping exposure sessions

Capacity was determined as the ability of HDL to inhibit LDL-induced oxidation of dihydrodichlorofluorescein into the fluorescent dichlorofluorescein. Capacity was expressed as an HDL oxidative index, determined by the ratio of dichlorofluorescein fluorescence in the presence and absence of HDL. An index of \< 1.0 denotes protective antioxidant HDL, whereas an index of \> 1.0 indicates pro-oxidant HDL.

Paraoxonase-1 (PON-1) Activity

时间窗: Pre- and post- the 30-minute smoking or vaping exposure sessions

PON-1 activity was determined by the ability of PON-1, associated with HDL, to hydrolyze paraoxon substrate. The hydrolysis of paraoxon (diethyl-p-nitrophenyl phosphate) to p-nitrophenol by PON-1 was determined by incubating 5 mL of plasma with 1.0 mM paraoxon in 100 mM tris-HCl buffer (pH, 8.5). Unit of Measure: expressed as micromoles of p-nitrophenol formed per minute for every 1 mL plasma.

Flow-Mediated Dilation (FMD)

时间窗: 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. Baseline diameter and velocity were recorded for 45 seconds and resumed 30 seconds before cuff deflation and continuously for 2 minutes after deflation to obtain true peak vasodilatory response.

Carotid-Femoral Pulse Wave Velocity (Cf-PWV)

时间窗: Pre- and post- the 30-minute smoking or vaping exposure sessions

Using applanation tonometry, cf-PWV was used to measure central arterial stiffness.

Arylesterase Activity

时间窗: Pre- and post- the 30-minute smoking or vaping exposure sessions.

Arylesterase activity (lipid peroxidation biomarker) was determined by the rate of hydrolysis of phenyl acetate to phenol. Briefly, 4 mL plasma was incubated with 3.5 mM phenyl acetate in 9 mM Tris-HCl buffer (pH, 8.0) containing 0.9 mM CaCl2 at RT. The kinetics of phenol formation were determined by recording the absorbance at 270 nm every 15 s for 2 min. Unit of Measure: nanomoles of product formed per minute per milliliter of plasma.

Tumor Necrosis Factor-α (TNFα) Concentrations

时间窗: Pre- and post- the 30-minute smoking or vaping exposure sessions

Plasma TNFα (inflammatory biomarker)

次要结局

  • Nicotine Levels(Pre- and post- the 30-minute smoking or vaping exposure sessions)
  • Flow-Mediated Dilation (FMD)(Effect of FMD with e-hookah vaping examined after pretreatment of intravenous infusion of antioxidant ascorbic acid (administered over 60 minutes at 0.5 mL min-1))
  • Endothelium-independent Vasodilator Function (Control Test for Endothelium-dependent Vasodilator Function)(Pre- and post- sublingual administration of nitroglycerin (0.15 mg), which was administrated before and after e-hookah vaping.)
  • Augmentation Index (AI)(Pre- and post- the 30-minute smoking or vaping exposure sessions)
  • Interleukin 6 (IL-6) Levels(A change between two points is reported below (e.g., value at post-exposure session minus value at pre-exposure session).)
  • Interleukin 10 (IL-10) Levels(A change between two points is reported below (e.g., value at post-exposure session minus value at pre-exposure session).)
  • Carbon Monoxide (CO) Levels(Pre- and post- the 30-minute smoking or vaping exposure sessions)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary Rezk-Hanna, PhD

Principal Investigator

University of California, Los Angeles

研究点 (2)

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