Acute Effects of Propylene Glycol/Glycerol Intake on Blood Parameters

Metabolic Complication Clinical Trial

— AEPGGIBP  

Official title:

Acute Effects of Propylene Glycol/Glycerol Intake on Cardiorespiratory Blood Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404011
• Other study ID #: Université Libre de Bruxelles
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: October 2018
• Source: Université Libre de Bruxelles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the acute effect of propylene glycol and glycerol intake on cardiorespiratory blood parameters.

Description:

Background : Propylene glycol/glycerol intake is increasingly popular. Acute effect of propylene glycol and glycerol intake on cardiorespiratory blood parameters is unknown. The investigators postulate that intake of propylene glycol and glycerol could modifiy cardiorespiratory blood parameters.

Aims of this study : to test the following hypotheses :

1) Acute intake of propylene glycol and glycerol modifies cardiorespiratory blood parameters.

To test this hypothesis, we will perform blood samples before and after intake of propylene glycol and glycerol. Participants will be tobacco smoker between 18 and 70 years old, with multiple cardiovascular risk factors, and who will undergo a cardiac catherization. After the cardiac catherization, the catheter will be used to perform serial blood samples.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Subject undergoing cardiac catherization

• Subject must be an active tobacco smoker

Exclusion Criteria:

• Symptoms of infection or inflammation

• Acute disease including heart rhythm disorder, acute coronary syndrome or decompensation of a chronic disease (heart failure, COPD,...)

• Unexpected and undesirable effects during the cardiac catherization procedure

• Respiratory failure requiring supplementary oxygen

Related Conditions & MeSH terms

• Metabolic Complication

Intervention

Other:
• Propylene glycol and Glycerol intake
Intake of 1 gram of propylene glycol/Glycerol mix (50:50). Blood sample before, 5 minutes and 20 minutes after intake.

Device:
• Mimicking intake
Mimicking propylene glycol/glycerol intake with the device turns off. Blood sample before, 5 minutes and 20 minutes after intake.

Locations

Country	Name	City	State
Belgium	Saint-Pierre Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Université Libre de Bruxelles

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorespiratory biological variables	Blood sample	5 minutes
Secondary	Cardiorespiratory biological variables	Blood sample	20 minutes