Snus and Home Blood Pressure
- Conditions
- Blood PressureDyslipidemiasDysglycemiaObesity
- Interventions
- Other: Snus with or without tobacco
- Registration Number
- NCT06019910
- Lead Sponsor
- University Hospital, Linkoeping
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 28
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Snus with or without tobacco Snus with or without tobacco Snus cessation followed by potential snus relapse
- Primary Outcome Measures
Name Time Method Home blood pressure during snus cessation 4-12 weeks Change in home blood pressure from baseline until week 4 and week 12 respectively
Home blood pressure during snus relapse 4-12 weeks Change in home blood pressure from week 0 of snus relapse until week 4 and week 12 respectively
- Secondary Outcome Measures
Name Time Method Body weight during snus relapse 4-12 weeks Change in body weight from week 0 of snus relapse until week 4 and week 12 respectively
Body weight during snus cessation 4-12 weeks Change in body weight from baseline until week 4 and week 12 respectively
Concentration of fasting plasma glucose during snus cessation 4-12 weeks Change in fasting plasma glucose from baseline until week 4 and week 12 respectively
Concentration of fasting plasma insulin during snus cessation 4-12 weeks Change in fasting plasma insulin from baseline until week 4 and week 12 respectively
Concentration of plasma lipids during snus cessation 4-12 weeks Change in plasma lipids from baseline until week 4 and week 12 respectively
Concentration of blood HbA1c during snus cessation 4-12 weeks Change in blood HbA1c from baseline until week 4 and week 12 respectively
Concentration of fasting plasma insulin during snus relapse 4-12 weeks Change in fasting plasma insulin from week 0 of snus relapse until week 4 and week 12 respectively
Concentration of blood HbA1c during snus relapse 4-12 weeks Change in blood HbA1c from week 0 of snus relapse until week 4 and week 12 respectively
Concentration of plasma lipids during snus relapse 4-12 weeks Change in plasma lipids from week 0 of snus relapse until week 4 and week 12 respectively
Concentration of fasting plasma glucose during snus relapse 4-12 weeks Change in fasting plasma glucose from week 0 of snus relapse until week 4 and week 12 respectively
Trial Locations
- Locations (1)
Primary Health Care Center Cityhälsan Centrum
🇸🇪Norrköping, Sweden