- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03410511
Propylene Glycol/Glycerol Intake and Cardiorespiratory Function (PGGICF)
Reversibility of Propylene Glycol/Glycerol Intake Effects on Cardiorespiratory Function
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Anderlecht
-
Brussels, Anderlecht, Belgium, 1070
- Erasme hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cardiorespiratory function
Time Frame: 4 hours
|
Continuous monitoring of cardiorespiratory function
|
4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in serum and urine proteomics profiles
Time Frame: 1 hour
|
Serum and urine proteomics
|
1 hour
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in serum and exhaled breath condensate metabolomics profiles
Time Frame: 1 hour
|
Serum and exhaled breath condensate metabolomics
|
1 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Philippe van de Borne, MD, PhD, Université Libre de Bruxelles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Wounds and Injuries
- Thoracic Injuries
- Lung Injury
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- P2016/466 / B406201629930
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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