Effects on Oxidative Stress and Platelet Activation of Traditional Cigarettes, E-cigarettes and IQOS Cigarettes: A Randomized in Vivo Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Endothelial dysfunction
研究概览
简要总结
Electronic cigarettes (E-cigarettes) and new heat-not-burn tobacco products such as IQOS®, an electronic device that heats a cigarette-like stick without combustion, are a modern and technological surrogate of traditional tobacco cigarettes (T-cigarettes), that are entering in the commercial market. While the negative effects of the traditional cigarette are well known, little data are reported in scientific literature on the risks on the health by these new smoking devices. Endothelial dysfunction evaluated by flow-mediated dilatation (FMD), oxidative stress and platelet activation have been recognized as a hallmark of preclinical systemic atherosclerosis and as a useful marker to stratify the risk of cardiovascular disease in patients at risk or with established clinically significant atherosclerosis. Since no data are reported about the effects of these new smoking device on oxidative stress, platelet activation and FMD, the investigators designed a human study assessing if these new smoking devices have effects on healthy smokers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Smokers volunteers, minimum age 18 years
排除标准
- •no history of acute or chronic organic, metabolic and inflammatory diseases;
- •no fever and infections in the last 3 months;
- •no history of cardiovascular pathological symptoms;
- •no allergies;
- •none of the participants took vitamin E, other antioxidant supplements or other drugs potentially affecting oxidative stress or FMD
- •women were not menstruating when the experiment was performed.
研究组 & 干预措施
Heat-not-burn tobacco products (IQOS)
smoke one IQOS cigarette (with a mean nicotine content of 0.6 mg according to package label).
干预措施: Smoke (Behavioral)
Traditional cigarette
smoke one Traditional cigarette (with a mean nicotine content of 0.6 mg according to package label) and in a sub-group smoke a sham cigarette (an traditional cigarette without combustion).
干预措施: Smoke (Behavioral)
Electronic cigarette
smoke a tobacco-flavored Electronic cigarette (9 puffs approximately equivalent to 0.6 mg of nicotine content) and in a sub-group smoke a sham cigarette (an electronic cigarette without nicotine).
干预措施: Smoke (Behavioral)
结局指标
主要结局
Endothelial dysfunction
时间窗: up to 24 weeks
flow-mediated dilatation (FMD) assessed by vascular ultrasound
Oxidative stress
时间窗: up to 24 weeks
Soluble Nox2-derived peptide, a direct marker of NADPH oxidase activation
次要结局
- Platelet activation(up to 24 weeks)
研究者
Roberto Carnevale
Principal Investigator
University of Roma La Sapienza
