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
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
- 是
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
Martin Chaumont
Principal investigator
Université Libre de Bruxelles
