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OpenTrials
Completed

NCT Number: NCT02532894

Effects of E-smoke on Levels of Endothelial Progenitor Cells and Microparticles in Healthy Volunteers

We plan to investigate the acute effects of inhaling e-cigarette vapor on cell function measured by microvesicles and endothelial progenitor cells. Micro vesicles are released upon either activation or apoptosis from different cell types such as platelets, leucocytes and endothelial cell. Endothelial progenitor cells are a type of stem cells that circulate in the blood with the ability to differentiate to endothelial cells. Endothelial progenitor cells are inversely correlated to cardiovascular risk factors.

As a secondary endpoint we plan to investigate exhaled nitric oxide - a common inflammation marker used in asthmatic patients - after inhalation of electronic cigarette vapor.

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Key information

Conditions

Healthy Behavior Smoking Vaping

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institutionen för kliniska vetenskaper, Danderyds sjukhus

Danderyd, Stockholm County, 18288, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy subjects
  • sporadic cigarette smoking (<9 cigarettes per month)

Exclusion criteria

  • Any form of cardiovascular disease
  • Any form of pulmonary disease like asthma or COPD
  • 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
  • Pregnancy

Treatment and study plan

Electronic cigarette

Device

Inhaling e-cigarette vapor

Primary outcomes

  1. Change in number of endothelial progenitor cells

    Time frame: 24 hours

  2. Change in number of micro vesicles

    Time frame: 24 hours

Secondary outcomes

  1. Change in exhaled nitric oxide

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Acronym: ESMOKE

Important dates

Study start
2014
Primary completion
2014
Study completion
2016
First posted
Aug 26, 2015
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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