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Snus and Home Blood Pressure

Primary Purpose

Blood Pressure, Dyslipidemias, Dysglycemia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Snus with or without tobacco
Sponsored by
University Hospital, Linkoeping
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Pressure

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Snus with or without tobacco

    Arm Description

    Snus cessation followed by potential snus relapse

    Outcomes

    Primary Outcome Measures

    Home blood pressure during snus cessation
    Change in home blood pressure from baseline until week 4 and week 12 respectively
    Home blood pressure during snus relapse
    Change in home blood pressure from week 0 of snus relapse until week 4 and week 12 respectively

    Secondary Outcome Measures

    Body weight during snus cessation
    Change in body weight from baseline until week 4 and week 12 respectively
    Concentration of plasma lipids during snus cessation
    Change in plasma lipids from baseline until week 4 and week 12 respectively
    Concentration of fasting plasma glucose during snus cessation
    Change in fasting plasma glucose from baseline until week 4 and week 12 respectively
    Concentration of fasting plasma insulin during snus cessation
    Change in fasting plasma insulin from baseline until week 4 and week 12 respectively
    Concentration of blood HbA1c during snus cessation
    Change in blood HbA1c from baseline until week 4 and week 12 respectively
    Body weight during snus relapse
    Change in body weight from week 0 of snus relapse until week 4 and week 12 respectively
    Concentration of plasma lipids during snus relapse
    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
    Change in fasting plasma glucose from week 0 of snus relapse until week 4 and week 12 respectively
    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
    Concentration of blood HbA1c during snus relapse
    Change in blood HbA1c from week 0 of snus relapse until week 4 and week 12 respectively

    Full Information

    First Posted
    July 30, 2023
    Last Updated
    September 2, 2023
    Sponsor
    University Hospital, Linkoeping
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06019910
    Brief Title
    Snus and Home Blood Pressure
    Official Title
    The Effects of Snus on Home Blood Pressure and Metabolism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 18, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital, Linkoeping

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blood Pressure, Dyslipidemias, Dysglycemia, Obesity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    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)
    Allocation
    N/A
    Enrollment
    28 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Snus with or without tobacco
    Arm Type
    Experimental
    Arm Description
    Snus cessation followed by potential snus relapse
    Intervention Type
    Other
    Intervention Name(s)
    Snus with or without tobacco
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Home blood pressure during snus cessation
    Description
    Change in home blood pressure from baseline until week 4 and week 12 respectively
    Time Frame
    4-12 weeks
    Title
    Home blood pressure during snus relapse
    Description
    Change in home blood pressure from week 0 of snus relapse until week 4 and week 12 respectively
    Time Frame
    4-12 weeks
    Secondary Outcome Measure Information:
    Title
    Body weight during snus cessation
    Description
    Change in body weight from baseline until week 4 and week 12 respectively
    Time Frame
    4-12 weeks
    Title
    Concentration of plasma lipids during snus cessation
    Description
    Change in plasma lipids from baseline until week 4 and week 12 respectively
    Time Frame
    4-12 weeks
    Title
    Concentration of fasting plasma glucose during snus cessation
    Description
    Change in fasting plasma glucose from baseline until week 4 and week 12 respectively
    Time Frame
    4-12 weeks
    Title
    Concentration of fasting plasma insulin during snus cessation
    Description
    Change in fasting plasma insulin from baseline until week 4 and week 12 respectively
    Time Frame
    4-12 weeks
    Title
    Concentration of blood HbA1c during snus cessation
    Description
    Change in blood HbA1c from baseline until week 4 and week 12 respectively
    Time Frame
    4-12 weeks
    Title
    Body weight during snus relapse
    Description
    Change in body weight from week 0 of snus relapse until week 4 and week 12 respectively
    Time Frame
    4-12 weeks
    Title
    Concentration of plasma lipids during snus relapse
    Description
    Change in plasma lipids from week 0 of snus relapse until week 4 and week 12 respectively
    Time Frame
    4-12 weeks
    Title
    Concentration of fasting plasma glucose during snus relapse
    Description
    Change in fasting plasma glucose from week 0 of snus relapse until week 4 and week 12 respectively
    Time Frame
    4-12 weeks
    Title
    Concentration of fasting plasma insulin during snus relapse
    Description
    Change in fasting plasma insulin from week 0 of snus relapse until week 4 and week 12 respectively
    Time Frame
    4-12 weeks
    Title
    Concentration of blood HbA1c during snus relapse
    Description
    Change in blood HbA1c from week 0 of snus relapse until week 4 and week 12 respectively
    Time Frame
    4-12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Peder af Geijerstam, MD
    Phone
    +460739597426
    Email
    peder.af.geijerstam@liu.se
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fredrik H Nyström, PhD, MD
    Organizational Affiliation
    Linkoeping University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30234752
    Citation
    Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; Authors/Task Force Members:. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension. J Hypertens. 2018 Oct;36(10):1953-2041. doi: 10.1097/HJH.0000000000001940. Erratum In: J Hypertens. 2019 Jan;37(1):226.
    Results Reference
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    PubMed Identifier
    29630702
    Citation
    Benowitz NL, Pipe A, West R, Hays JT, Tonstad S, McRae T, Lawrence D, St Aubin L, Anthenelli RM. Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers: A Randomized Clinical Trial. JAMA Intern Med. 2018 May 1;178(5):622-631. doi: 10.1001/jamainternmed.2018.0397.
    Results Reference
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    PubMed Identifier
    25323263
    Citation
    Middlekauff HR, Park J, Moheimani RS. Adverse effects of cigarette and noncigarette smoke exposure on the autonomic nervous system: mechanisms and implications for cardiovascular risk. J Am Coll Cardiol. 2014 Oct 21;64(16):1740-50. doi: 10.1016/j.jacc.2014.06.1201.
    Results Reference
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    PubMed Identifier
    33230755
    Citation
    Martinez-Morata I, Sanchez TR, Shimbo D, Navas-Acien A. Electronic Cigarette Use and Blood Pressure Endpoints: a Systematic Review. Curr Hypertens Rep. 2020 Nov 23;23(1):2. doi: 10.1007/s11906-020-01119-0.
    Results Reference
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    PubMed Identifier
    21633341
    Citation
    Audrain-McGovern J, Benowitz NL. Cigarette smoking, nicotine, and body weight. Clin Pharmacol Ther. 2011 Jul;90(1):164-8. doi: 10.1038/clpt.2011.105. Epub 2011 Jun 1. No abstract available.
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    PubMed Identifier
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    Citation
    Chiolero A, Faeh D, Paccaud F, Cornuz J. Consequences of smoking for body weight, body fat distribution, and insulin resistance. Am J Clin Nutr. 2008 Apr;87(4):801-9. doi: 10.1093/ajcn/87.4.801.
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    PubMed Identifier
    3941694
    Citation
    Hofstetter A, Schutz Y, Jequier E, Wahren J. Increased 24-hour energy expenditure in cigarette smokers. N Engl J Med. 1986 Jan 9;314(2):79-82. doi: 10.1056/NEJM198601093140204.
    Results Reference
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    Snus and Home Blood Pressure

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