跳至主要内容
临床试验/NCT03036644
NCT03036644已完成不适用

Effects of Electronic Cigarette Vaporization at High Temperature in Comparison to Tobacco Smoking on Cardiovascular Function and Oxidative Stress in Electronic Cigarette Users and Regular Tobacco Smokers

Université Libre de Bruxelles2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年1月15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
25
试验地点
2
主要终点
Change in subcutaneous flux

研究概览

简要总结

Background: Electronic cigarettes (e-cigarettes) are battery-powered devices heating a liquid (e-liquid) composed of propylene glycol and/or vegetable glycerin, and most commonly, nicotine to form an aerosol (vapor) that is inhaled (i.e. "vaped"). Scarce and conflicting data are available regarding the cardiovascular toxicity of e-cigarettes. We wish to determine the acute effects of propylene glycol/vegetable glycerin and nicotine vaporization at high temperature in comparison to tobacco cigarette smoking on several advanced cardiovascular parameters in healthy chronic e-cigarettes users and tobacco smokers. Furthermore, a large range of plasma, urine and respiratory oxidative stress markers will be quantified. By this way, we aim to demonstrate that e-cigarettes-induced systemic oxidative stress could be linked to cardiovascular toxicity. To the best of our knowledge, this is the first project that evaluates the effects of e-cigarettes vaping in comparison to tobacco cigarette smoking on the cardiovascular system in relation to vaporization temperature, nicotine delivery and oxidative stress.

Aims of the study: This study tests the following hypotheses: 1) acute high temperature vaporization of propylene glycol and vegetable glycerin has no deleterious effects on cardiovascular parameters in comparison to tobacco smoking; 2) Tobacco smoking rises plasma and urine oxidative stress biomarkers. On the contrary, acute and chronic e-cigarettes vaping don't rise these biomarkers. At a cellular level, plasma of smokers but not vapers increases superoxide anion production.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects

排除标准

  • Any form of cardiovascular disease
  • Any form of pulmonary disease like asthma or COPD
  • Any form of systemic or chronic disorder
  • Active allergy within 4 weeks of the study
  • Symptoms of infection or inflammation within 4 weeks of the study
  • Pregnancy

结局指标

主要结局

Change in subcutaneous flux

时间窗: 1 hour

次要结局

  • Change in Plasma and urine oxidative stress markers(1 hour)
  • Change in aortic stiffness(10 minutes)
  • Change in heart rate variability(10 minutes)
  • Change in baroreflex sensitivity(10 minutes)

研究者

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

Martin Chaumont

Principal investigator

Université Libre de Bruxelles

研究点 (2)

Loading locations...

相似试验

Comparison of Electronic Cigarettes and Tobacco... | 临床试验