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Propylene Glycol/Glycerol Intake and Cardiorespiratory Function (PGGICF)

Primary Purpose

Lung Injury

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Nicotine free intake
Nicotine intake
Cessation intake
Sponsored by
Université Libre de Bruxelles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lung Injury

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Erasme Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Nicotine free intake

Nicotine intake

Cessation intake

Arm Description

The participant will wean off nicotine during five days before the experimental session. At the start of the experimental session, participants will be exposed to acute propylene glycol/glycerol (mix 50:50) intake.

The participant will pursuit his regular nicotinic propylene/glycerol intake five days before the experimental session. At the start of the experimental session, participants will be exposed to acute propylene glycol/glycerol/nicotine (mix 50:50) intake.

The participant will completely stop his regular nicotinic propylene/glycerol intake during five days before the session. At the start of the experimental session, participants will mimick intake with the device turns off.

Outcomes

Primary Outcome Measures

Change in cardiorespiratory function
Continuous monitoring of cardiorespiratory function

Secondary Outcome Measures

Change in serum and urine proteomics profiles
Serum and urine proteomics

Full Information

First Posted
January 11, 2018
Last Updated
November 2, 2020
Sponsor
Université Libre de Bruxelles
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1. Study Identification

Unique Protocol Identification Number
NCT03410511
Brief Title
Propylene Glycol/Glycerol Intake and Cardiorespiratory Function
Acronym
PGGICF
Official Title
Reversibility of Propylene Glycol/Glycerol Intake Effects on Cardiorespiratory Function
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Libre de Bruxelles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Injury

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nicotine free intake
Arm Type
Experimental
Arm Description
The participant will wean off nicotine during five days before the experimental session. At the start of the experimental session, participants will be exposed to acute propylene glycol/glycerol (mix 50:50) intake.
Arm Title
Nicotine intake
Arm Type
Experimental
Arm Description
The participant will pursuit his regular nicotinic propylene/glycerol intake five days before the experimental session. At the start of the experimental session, participants will be exposed to acute propylene glycol/glycerol/nicotine (mix 50:50) intake.
Arm Title
Cessation intake
Arm Type
Experimental
Arm Description
The participant will completely stop his regular nicotinic propylene/glycerol intake during five days before the session. At the start of the experimental session, participants will mimick intake with the device turns off.
Intervention Type
Other
Intervention Name(s)
Nicotine free intake
Intervention Description
The participant will wean off nicotine during five days before the experimental session. At the start of the experimental session, participants will be exposed to acute propylene glycol/glycerol (mix 50:50) intake.
Intervention Type
Other
Intervention Name(s)
Nicotine intake
Intervention Description
The participant will pursuit his regular nicotinic propylene/glycerol intake five days before the experimental session. At the start of the experimental session, participants will be exposed to acute propylene glycol/glycerol (mix 50:50) intake.
Intervention Type
Other
Intervention Name(s)
Cessation intake
Intervention Description
The participant will completely stop his regular nicotinic propylene/glycerol intake during five days before the session. At the start of the experimental session, participants will mimick intake with the device turns off.
Primary Outcome Measure Information:
Title
Change in cardiorespiratory function
Description
Continuous monitoring of cardiorespiratory function
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Change in serum and urine proteomics profiles
Description
Serum and urine proteomics
Time Frame
1 hour
Other Pre-specified Outcome Measures:
Title
Change in serum and exhaled breath condensate metabolomics profiles
Description
Serum and exhaled breath condensate metabolomics
Time Frame
1 hour

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe van de Borne, MD, PhD
Organizational Affiliation
Université Libre de Bruxelles
Official's Role
Study Director
Facility Information:
Facility Name
Erasme Hospital
City
Brussels
State/Province
Anderlecht
ZIP/Postal Code
1070
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
IPD Sharing Time Frame
Immediately following publication. No end date.
IPD Sharing Access Criteria
Any purpose Proposals should be directed to martin.chaumont@ulb.ac.be

Learn more about this trial

Propylene Glycol/Glycerol Intake and Cardiorespiratory Function

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