Snus and Home Blood Pressure

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Snus on Home Blood Pressure and Metabolism

Conditions
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Blood Pressure, Dyslipidemias, Dysglycemia, Obesity

Intervention / Treatment
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* Other: Snus with or without tobacco


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Sequential Assignment
Interventional Model Description: At baseline, all participants use snus, and will be asked to quit their usage. They will then be followed for up to 12 weeks. If and when they relapse in snus use, another 12 weeks will commence, during which the same measurements will repeated but for a second period of up to 12 weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Snus with or without tobacco<br>Snus cessation followed by potential snus relapse | Other: Snus with or without tobacco<br>* At baseline, participants have used the intervention daily for at least 30 days. They will then cease usage of the intervention abruptly. After 3 weeks, they may continue to abstain from the intervention or relapse at their own discretion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Home blood pressure during snus cessation | Change in home blood pressure from baseline until week 4 and week 12 respectively | 4-12 weeks | 
| Home blood pressure during snus relapse | Change in home blood pressure from week 0 of snus relapse until week 4 and week 12 respectively | 4-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight during snus cessation | Change in body weight from baseline until week 4 and week 12 respectively | 4-12 weeks | 
| Concentration of plasma lipids during snus cessation | Change in plasma lipids from baseline until week 4 and week 12 respectively | 4-12 weeks | 
| Concentration of fasting plasma glucose during snus cessation | Change in fasting plasma glucose from baseline until week 4 and week 12 respectively | 4-12 weeks | 
| Concentration of fasting plasma insulin during snus cessation | Change in fasting plasma insulin from baseline until week 4 and week 12 respectively | 4-12 weeks | 
| Concentration of blood HbA1c during snus cessation | Change in blood HbA1c from baseline until week 4 and week 12 respectively | 4-12 weeks | 
| Body weight during snus relapse | Change in body weight from week 0 of snus relapse until week 4 and week 12 respectively | 4-12 weeks | 
| Concentration of plasma lipids during snus relapse | Change in plasma lipids from week 0 of snus relapse until week 4 and week 12 respectively | 4-12 weeks | 
| Concentration of fasting plasma glucose during snus relapse | Change in fasting plasma glucose from week 0 of snus relapse until week 4 and week 12 respectively | 4-12 weeks | 
| Concentration of fasting plasma insulin during snus relapse | Change in fasting plasma insulin from week 0 of snus relapse until week 4 and week 12 respectively | 4-12 weeks | 
| Concentration of blood HbA1c during snus relapse | Change in blood HbA1c from week 0 of snus relapse until week 4 and week 12 respectively | 4-12 weeks |