e-Cigarettes: Formaldehyde DNA Adducts, Oxidative Damage, and Potential Toxicity and Carcinogenesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- DNA Adducts
研究概览
简要总结
This study will examine the level of toxicity of e-cigarette use compared to smokers and nonsmokers including inflammation markers, toxicant and carcinogen exposure. Additionally, the study will look at the effect of varying voltage levels for e-cigarette users.
详细描述
In this observational study, e-cigarette users, smokers, and non-users of e-cigarette or tobacco products (up to 134 per group) will be recruited from the Minneapolis-St. Paul area. This research will be conducted at the Tobacco Research Programs at the University of Minnesota. Subjects are screened for eligibility over the phone. If eligible after the phone screen, participants will be invited to attend orientation screening visit in the clinic where consent will be obtained and subjects will complete forms about their tobacco and e-cigarette use and medical history. Subjects who eligible will be asked to return for six visits over the course of six months.
At these appointments, subjects will provide biological specimen samples (buccal cells, urine and blood). Saliva will be collected before and after a smoking or vaping session. Non-users will only have 1 saliva collection.
Subjects will be asked for information pertaining to and e-cigarette and tobacco use and overall health.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Good physical health with no unstable medical conditions; Able to provide written informed consent; Stable and good mental health;
- •Meet criteria for 1 of three groups:
- •Regular smokers confirmed by CO;
- •E-cigarette users (exclusive e-cigarette use for 3 months); Non-Tobacco Users
- •Non-smokers
排除标准
- •Unstable medical condition Not willing to attend visits
结局指标
主要结局
DNA Adducts
时间窗: 6 months
Formation of Formaldehyde DNA Adducts in oral cells before and after smoking or vaping
次要结局
- TNE(6 months)
- Urinary 8-iso-PGF-2α(6 months)
- Urinary PGEM(6 months)
- C-reactive protein(6 months)