Clinical trial NCT06019910: Snus and Home Blood Pressure
Official title: The Effects of Snus on Home Blood Pressure and Metabolism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Pressure
Dyslipidemias
Dysglycemia
Obesity
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Home blood pressure during snus cessation
timeFrame: 4-12 weeks
measure: Home blood pressure during snus relapse
timeFrame: 4-12 weeks
Secondary outcomes:
measure: Body weight during snus cessation
timeFrame: 4-12 weeks
measure: Concentration of plasma lipids during snus cessation
timeFrame: 4-12 weeks
measure: Concentration of fasting plasma glucose during snus cessation
timeFrame: 4-12 weeks
measure: Concentration of fasting plasma insulin during snus cessation
timeFrame: 4-12 weeks
measure: Concentration of blood HbA1c during snus cessation
timeFrame: 4-12 weeks
measure: Body weight during snus relapse
timeFrame: 4-12 weeks
measure: Concentration of plasma lipids during snus relapse
timeFrame: 4-12 weeks
measure: Concentration of fasting plasma glucose during snus relapse
timeFrame: 4-12 weeks
measure: Concentration of fasting plasma insulin during snus relapse
timeFrame: 4-12 weeks
measure: Concentration of blood HbA1c during snus relapse
timeFrame: 4-12 weeks
Other outcomes:
Locations:
city: Norrköping
country: Sweden
facility: Primary Health Care Center Cityhälsan Centrum
Study officials:
affiliation: Linkoeping University
name: Fredrik H Nyström, PhD, MD
role: PRINCIPAL_INVESTIGATOR
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