Cardiovascular Effects of Chronic Snus Use

Completed

• Conditions: Tobacco Dependence; Vascular Complications; Vascular Stiffness

• Registration Number: NCT02564289
• Lead Sponsor: Umeå University

Brief Summary

The current study proposes to investigate the effects of chronic snus use on the blood vessels. Several cardiovascular endpoints are measured using various methods in healthy daily snus users as well as in healthy matched controls.

Detailed Description

The Swedish moist oral snuff known as "snus" has previously been found primarily in Scandinavia. In Sweden approximately 1 in 5 men are habitual users of snus. It is estimated that 3-4% of the female population are regular users. However, the last few years has seen a shift in the global tobacco industry towards finding novel ways of entering the smokeless tobacco (ST) markets. In the United States both Camel and Marlboro brands, among others, have launched an array of ST products similar to Swedish snus. Since its launch in 2007, the US snus market has continued to grow at an exponential rate and now sells approximately 50 million cans a year.

Smoking has been studied extensively and been undoubtedly linked to a range of detrimental health effects, including cardiovascular disease. As snus has until recently been available in a limited Scandinavian market, few experimental and epidemiological studies have been performed.

A recent meta-analysis found snus to be associated with heart failure and higher risk of fatal myocardial infarctions and stroke. Following myocardial infarction, discontinuation of snus use was associated with a 50% decreased risk of mortality.

With new emerging markets worldwide publicizing the product as a discrete and healthier alternative to cigarettes, it has become all the more imperative to study the health effects of this smokeless tobacco. Using well validated methods the investigators intend to study the possible effects of chronic snus use on vascular endothelial function, thrombosis, circulating microparticles in blood and arterial stiffness.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-29
• Study First Submitted QC: 2015-09-29
• Study First Posted: 2015-09-30
• Primary Completion: 2016-02
• Status Verified: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-18
• Last Update Posted: 2016-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• Normal clinical examination
• Normal ECG
• Normal routine blood test including serum lipids and HbA1C

Exclusion Criteria

• Any form of cardiovascular disease
• Any form of systemic or chronic disorder like rheumatologic or metabolic diseases.
• Active allergy within 4 weeks of the study
• Symptoms of infection or inflammation within 4 weeks of the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Venous occlusion plethysmography	1 day	Venous occlusion plethysmography is a semi-invasive method of estimating vascular function in which brachial forearm blood flow is measured. In combination with intra-arterial infusion of substances with vasodilatory effects (for example bradykinin, sodium nitroprusside and acetylcholine) this method is considered the "golden standard" for assessing endothelial function. Measurements are given in ml/100 ml tissue/min.

Secondary Outcome Measures

Name	Time	Method
Endothelial progenitor cells	1 day	Blood sample, measured as CD34+KDR+(KDR:vascular endothelial growth factor receptor 2) double positive cells, and results are presented as the number of EPC events.
Circulating microvesicles	1 day	Blood sample, expressed in 10\^6MVs/L
Arterial Stiffness	1 day	PWA, PWV. Expressed as Pulse wave velocity (m/s) och augmentation index adjusted for pulse 75 (%).

Trial Locations

Locations (1)

Dept of Medicine, Lung and Allergy section, University Hospital; 🇸🇪 Umeå, Västerbotten, Sweden