NCT02564289

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 21, 2016

Status Verified

March 1, 2016

Enrollment Period

5 months

First QC Date

September 29, 2015

Last Update Submit

March 18, 2016

Conditions

Vascular ComplicationsVascular StiffnessTobacco Dependence

Keywords

microvesicles, microparticlesPlethysmographySnusArterial StiffnessEPC

Outcome Measures

Primary Outcomes (1)

  • Venous occlusion plethysmography

    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.

    1 day

Secondary Outcomes (3)

  • Circulating microvesicles

    1 day

  • Endothelial progenitor cells

    1 day

  • Arterial Stiffness

    1 day

Study Arms (2)

Healthy Chronic snus users

Healthy subjects that used snus for more than 15 years.

Healthy Controls

Healthy subjects that are never-users of snus.

Eligibility Criteria

Age30 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

25 healthy non-smoking males with regular snus consumption and 25 healthy non-smoking and non-snus using. Healthy volunteers were recruited in Umeå and surrounding communities.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Medicine, Lung and Allergy section, University Hospital

Umeå, Västerbotten County, Sweden

Location

Related Publications (7)

  • Hergens MP, Alfredsson L, Bolinder G, Lambe M, Pershagen G, Ye W. Long-term use of Swedish moist snuff and the risk of myocardial infarction amongst men. J Intern Med. 2007 Sep;262(3):351-9. doi: 10.1111/j.1365-2796.2007.01816.x.

    PMID: 17697156BACKGROUND

  • Bolinder G, Alfredsson L, Englund A, de Faire U. Smokeless tobacco use and increased cardiovascular mortality among Swedish construction workers. Am J Public Health. 1994 Mar;84(3):399-404. doi: 10.2105/ajph.84.3.399.

    PMID: 8129055BACKGROUND

  • Rohani M, Agewall S. Oral snuff impairs endothelial function in healthy snuff users. J Intern Med. 2004 Mar;255(3):379-83. doi: 10.1046/j.1365-2796.2003.01279.x.

    PMID: 14871462BACKGROUND

  • Boffetta P, Straif K. Use of smokeless tobacco and risk of myocardial infarction and stroke: systematic review with meta-analysis. BMJ. 2009 Aug 18;339:b3060. doi: 10.1136/bmj.b3060.

    PMID: 19690343BACKGROUND

  • Arefalk G, Hambraeus K, Lind L, Michaelsson K, Lindahl B, Sundstrom J. Discontinuation of smokeless tobacco and mortality risk after myocardial infarction. Circulation. 2014 Jul 22;130(4):325-32. doi: 10.1161/CIRCULATIONAHA.113.007252. Epub 2014 Jun 23.

    PMID: 24958793BACKGROUND

  • Arefalk G, Hergens MP, Ingelsson E, Arnlov J, Michaelsson K, Lind L, Ye W, Nyren O, Lambe M, Sundstrom J. Smokeless tobacco (snus) and risk of heart failure: results from two Swedish cohorts. Eur J Prev Cardiol. 2012 Oct;19(5):1120-7. doi: 10.1177/1741826711420003. Epub 2011 Aug 9.

    PMID: 21828223BACKGROUND

  • Mobarrez F, Antoniewicz L, Bosson JA, Kuhl J, Pisetsky DS, Lundback M. The effects of smoking on levels of endothelial progenitor cells and microparticles in the blood of healthy volunteers. PLoS One. 2014 Feb 28;9(2):e90314. doi: 10.1371/journal.pone.0090314. eCollection 2014.

    PMID: 24587320BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, Urine samples

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Jenny A Bosson, MD,PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 29, 2015

First Posted

September 30, 2015

Study Start

September 1, 2015

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

March 21, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)