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CompletedNCT03410511PGGICFUpdated Nov 3, 2020

Propylene Glycol/Glycerol Intake and Cardiorespiratory Function

An interventional study of Nicotine free intake and Nicotine intake in Lung Injury, sponsored by Université Libre de Bruxelles. Completed at 1 site in Belgium. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-03.

Sponsored by Université Libre de Bruxelles · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Male
01

Study summary

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

Read the 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.
02

Conditions studied

  • Lung Injury

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03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Chronic or acute illness
  • Substance abuse
  • Chronic medication intake
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Nicotine free intake

    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.

    Other: Nicotine free intake

  • Experimental
    Nicotine 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.

    Other: Nicotine intake

  • Experimental
    Cessation 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.

    Other: Cessation intake

Interventions

  • OtherNicotine free intake

    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.

  • OtherNicotine 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 (mix 50:50) intake.

  • OtherCessation 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.

05

What researchers measure

Primary outcomes

  1. Change in cardiorespiratory function

    Continuous monitoring of cardiorespiratory function

    Time frame: 4 hours

Secondary outcomes

  1. Change in serum and urine proteomics profiles

    Serum and urine proteomics

    Time frame: 1 hour

Other outcomes

  1. Change in serum and exhaled breath condensate metabolomics profiles

    Serum and exhaled breath condensate metabolomics

    Time frame: 1 hour

06

Study locations

1 site
  • Erasme Hospital
    Brussels, Anderlecht 1070, Belgium
07

References and documents

Study documents

  • Protocol, analysis plan and consent form · Jan 15, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

08

Registry details

Key details

Study ID
NCT03410511
Lead sponsor
Université Libre de Bruxelles
Responsible party
Martin Chaumont (Principal investigator, Université Libre de Bruxelles) — Principal investigator
First posted
Jan 25, 2018
Start date
Jan 15, 2018
Primary completion
Jun 30, 2019
Completion
Jun 30, 2020
Last update
Nov 3, 2020

Study contacts

Philippe van de Borne, MD, PhD
study director · Université Libre de Bruxelles

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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