Propylene Glycol/Glycerol Intake and Cardiorespiratory Function

Not Applicable

Completed

• Conditions: Lung Injury

• Registration Number: NCT03410511
• Lead Sponsor: Université Libre de Bruxelles

Brief Summary

Propylene glycol/Glycerol intake is increasingly popular. The propylene glycol/glycerol intake effects on cardiorespiratory function are unknown.

Detailed Description

Background. Propylene glycol/Glycerol intake is increasingly popular. The propylene glycol/glycerol intake effects on cardiorespiratory function are unknown. Weaning of propylene glycol/glycerol could allows a quick clearance of propylene glycol/glycerol from the body, with subsequent recovery of cardiorespiratory function.

Specific aim of the research. This research proposal tests the following hypothesis regarding the reversibility of propylene glycol/glycerol and nicotine intake:

* Propylene glycol/glycerol cessation restores cardiorespiratory function.

* Chronic propylene glycol/glycerol and propylene glycol/glycerol/nicotine intake induces specific serum and urine proteomics profile, which are partially reversed after cessation.

* Chronic propylene glycol/glycerol and propylene glycol/glycerol/nicotine intake induces specific serum and urine metabolomics profile, which are partially reversed after cessation.

Study Timeline

• Study First Submitted: 2018-01-11
• Study Start: 2018-01-15
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-25
• Primary Completion: 2019-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Subject must be regular propylene glycol/glycerol/nicotine intake users since at least 1 year
• Subject must be former smokers

Exclusion Criteria

• Chronic or acute illness
• Substance abuse
• Chronic medication intake

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in cardiorespiratory function	4 hours	Continuous monitoring of cardiorespiratory function

Secondary Outcome Measures

Name	Time	Method
Change in serum and urine proteomics profiles	1 hour	Serum and urine proteomics

Trial Locations

Locations (1)

Erasme Hospital; 🇧🇪 Brussels, Anderlecht, Belgium