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

Healthy Clinical Trial

— ESMOKE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02532894
• Other study ID #: 214/552-31/4
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: March 2016

Study information

• Verified date: October 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2016
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Electronic cigarette
Inhaling e-cigarette vapor

Locations

Country	Name	City	State
Sweden	Institutionen för kliniska vetenskaper, Danderyds sjukhus	Danderyd	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of endothelial progenitor cells		24 hours
Primary	Change in number of micro vesicles		24 hours
Secondary	Change in exhaled nitric oxide		24 hours