Effects of E-smoke on Levels of Endothelial Progenitor Cells and Microparticles in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in number of endothelial progenitor cells
研究概览
简要总结
We plan to investigate the acute effects of inhaling e-cigarette vapor on cell function measured by microvesicles and endothelial progenitor cells. Micro vesicles are released upon either activation or apoptosis from different cell types such as platelets, leucocytes and endothelial cell. Endothelial progenitor cells are a type of stem cells that circulate in the blood with the ability to differentiate to endothelial cells. Endothelial progenitor cells are inversely correlated to cardiovascular risk factors.
As a secondary endpoint we plan to investigate exhaled nitric oxide - a common inflammation marker used in asthmatic patients - after inhalation of electronic cigarette vapor.
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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects
- •sporadic cigarette smoking (<9 cigarettes per month)
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 like rheumatologic or metabolic diseases.
- •Active allergy within 4 weeks of the study
- •Symptoms of infection or inflammation within 4 weeks of the study
- •Pregnancy
研究组 & 干预措施
Control
Esmoke
Inhaling e-cigarette vapor
干预措施: Electronic cigarette (Device)
结局指标
主要结局
Change in number of endothelial progenitor cells
时间窗: 24 hours
Change in number of micro vesicles
时间窗: 24 hours
次要结局
- Change in exhaled nitric oxide(24 hours)
研究者
Magnus Lundbäck
MD, PhD,
Karolinska Institutet