The Effects of Snus on Home Blood Pressure and Metabolism
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Home blood pressure during snus cessation
研究概览
简要总结
Snus is a type of snuff that is administered sublabially, that has not been studied regarding the effects on home blood pressure and metabolism on a longer time frame. The primary aim of this study is to evaluate the effect of snus on home BP within weeks to months in former snus users who continue to not use snus or relapse in daily snus use, respectively. The secondary aim is to evaluate the effects on metabolic measurements. The hypothesis is that BP will increase amongst the participants that resume snus intake.
28 healthy volunteers with a pre-existing daily use of snus will be recruited and followed during snus cessation. Home blood pressure, lipid and metabolic markers will be measured before and after snus cessation, as well as after snus relapse if such a relapse occurs.
详细描述
Both elevated blood pressure (BP) and cigarette smoking increases the risk of cardiovascular disease. Nicotine, through effects on the nervous system and catecholamine release, increases BP and heart rate, peaking 5-10 minutes after exposure, after which tolerance to nicotine reduces its hemodynamic effects. Smoking also increases energy expenditure, but studies on smoking and long-term metabolism have shown conflicting results.
Snus is a type of snuff that is administered sublabially, that has not been studied regarding the effects on home blood pressure and metabolism on a longer time frame. The primary aim of this study is to evaluate the effect of snus on home BP within weeks to months in former snus users who continue to not use snus or relapse in daily snus use, respectively. The secondary aim is to evaluate the effects on metabolic measurements. The hypothesis is that BP will increase amongst the participants that resume snus intake.
28 healthy volunteers with a pre-existing daily use of snus will be recruited and followed during snus cessation for 3 months. Home blood pressure, lipid and metabolic markers will be measured before and after snus cessation. Furthermore, for participants which relapse in snus use, the same measurements will be followed for an additional 3 months. Home blood pressure will be measured daily, and participants will also report the amount of snus use each day. At week 0, 4 and 12 of snus cessation and snus relapse, the following measurements will also be made: body weight as well as plasma glucose, blood glycated hemoglobin (HbA1c), serum insulin, plasma lipid profile (total cholesterol, low-density lipoprotein, high-density lipoprotein, and triglycerides), plasma hsCRP, plasma creatinine, plasma sodium, and plasma potassium.
As reimbursement, participants will receive (at least) 1000 Swedish krona (Approx 94 US dollar) for the drawing of blood tests. All participants will give written, informed consent prior to participation. The study will comply with the declaration of Helsinki and be approved by the Swedish Ethical Review Authority. Prior to commencement, the study will be registered at ClinicalTrials.gov.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •daily use (defined as at least once daily for at least 1 month) o snus
- •the ability to use online questionnaires written and answered in Swedish
排除标准
- •simultaneous use of any other nicotine or tobacco product (including cigarette smoking, e-cigarettes, and nicotine replacement therapy)
- •drug use (including cannabis)
- •alcohol dependence
- •known cardiovascular disease (including hypertension, previous myocardial infarction, stroke, peripheral arterial disease, or angina pectoris), kidney disease, hormonal disease (including diabetes mellitus) or eating disorder
- •current or planned pregnancy.
结局指标
主要结局
Home blood pressure during snus cessation
时间窗: 4-12 weeks
Change in home blood pressure from baseline until week 4 and week 12 respectively
Home blood pressure during snus relapse
时间窗: 4-12 weeks
Change in home blood pressure from week 0 of snus relapse until week 4 and week 12 respectively
次要结局
- Body weight during snus cessation(4-12 weeks)
- Concentration of fasting plasma glucose during snus cessation(4-12 weeks)
- Concentration of fasting plasma insulin during snus cessation(4-12 weeks)
- Body weight during snus relapse(4-12 weeks)
- Concentration of plasma lipids during snus cessation(4-12 weeks)
- Concentration of blood HbA1c during snus cessation(4-12 weeks)
- Concentration of fasting plasma insulin during snus relapse(4-12 weeks)
- Concentration of blood HbA1c during snus relapse(4-12 weeks)
- Concentration of plasma lipids during snus relapse(4-12 weeks)
- Concentration of fasting plasma glucose during snus relapse(4-12 weeks)
研究者
Fredrik H Nystrom
Professor of internal medicine and endocrinology
University Hospital, Linkoeping