Obesity Clinical Trial
Official title:
The Effects of Snus on Home Blood Pressure and Metabolism
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.
Status | Recruiting |
Enrollment | 28 |
Est. completion date | December 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Primary Health Care Center Cityhälsan Centrum | Norrköping |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Linkoeping |
Sweden,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Home blood pressure during snus cessation | Change in home blood pressure from baseline until week 4 and week 12 respectively | 4-12 weeks | |
Primary | 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 | Body weight during snus cessation | Change in body weight from baseline until week 4 and week 12 respectively | 4-12 weeks | |
Secondary | Concentration of plasma lipids during snus cessation | Change in plasma lipids from baseline until week 4 and week 12 respectively | 4-12 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Concentration of blood HbA1c during snus cessation | Change in blood HbA1c from baseline until week 4 and week 12 respectively | 4-12 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |