Metabolic ComplicationAEPGGIBPNCT03404011
Acute Effects of Propylene Glycol/Glycerol Intake on Blood Parameters
A study testing Propylene glycol and Glycerol intake and Mimicking intake in people with Metabolic Complication, run by Université Libre de Bruxelles at 1 site in Belgium.
Trial summary
The aim of this study is to evaluate the acute effect of propylene glycol and glycerol intake on cardiorespiratory blood parameters. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Complication
- What is being tested?
- Propylene glycol and Glycerol intake and Mimicking intake
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jan 2018to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject undergoing cardiac catherization
- Subject must be an active tobacco smoker
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Propylene Glycol/Glycerol Intake on Cardiorespiratory Blood Parameters
The aim of this study is to evaluate the acute effect of propylene glycol and glycerol intake on cardiorespiratory blood parameters.
Read the detailed 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 :
- 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.
- Conditions
- Metabolic Complication
- Being tested
- Propylene glycol and Glycerol intake, Mimicking intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propylene glycol and Glycerol intakeOther
Intake of 1 gram of propylene glycol/Glycerol mix (50:50). Blood sample before, 5 minutes and 20 minutes after intake.
Mimicking intakeDevice
Mimicking propylene glycol/glycerol intake with the device turns off. Blood sample before, 5 minutes and 20 minutes after intake.
| Study group | Role | What they receive |
|---|---|---|
| Propylene glycol and Glycerol intake | Experimental | One gram intake of a Propylene glycol/Glycerol mix (50:50) Receives: Other: Propylene glycol and Glycerol intake |
| Mimicking intake | Placebo comparator | Mimicking Propylene glycol/Glycerol intake with the device turns off Receives: Device: Mimicking intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory biological variables
Blood sample
Measured: 5 minutes
Secondary outcomes (1)
Cardiorespiratory biological variables
Blood sample
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start15 Jan 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Chaumont, Université Libre de Bruxelles
- Investigators
- Martin Chaumont, MD, Principal investigator, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404011
- Sponsor's protocol ID
- Université Libre de Bruxelles
- Acronym
- AEPGGIBP
- Status last verified
- Oct 2018
- First submitted
- 11 Jan 2018
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared upon reasonnable request
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Propylene Glycol/Glycerol Intake on Cardiorespiratory Blood Parameters
- ClinicalTrials.gov ID
- NCT03404011
- Acronym / sponsor ID
- AEPGGIBP / Université Libre de Bruxelles
- Conditions
- Metabolic Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the acute effect of propylene glycol and glycerol intake on cardiorespiratory blood parameters.
Detailed 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 :
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propylene glycol and Glycerol intake | Experimental | Other: Propylene glycol and Glycerol intakeOne gram intake of a Propylene glycol/Glycerol mix (50:50) |
| Mimicking intake | Placebo comparator | Device: Mimicking intakeMimicking Propylene glycol/Glycerol intake with the device turns off |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject undergoing cardiac catherization
- Subject must be an active tobacco smoker
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propylene glycol and Glycerol intakeIntake of 1 gram of propylene glycol/Glycerol mix (50:50). Blood sample before, 5 minutes and 20 minutes after intake. | Other | Propylene glycol and Glycerol intake |
| Mimicking intakeMimicking propylene glycol/glycerol intake with the device turns off. Blood sample before, 5 minutes and 20 minutes after intake. | Device | Mimicking intake |
Primary outcome
Cardiorespiratory biological variables
Time frame: 5 minutes
Blood sample
1 secondary outcome
Cardiorespiratory biological variables
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: Undecided. Data will be shared upon reasonnable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Chaumont, MD principal investigator
Université Libre de Bruxelles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propylene glycol and Glycerol intake and Mimicking intake in people with Metabolic Complication, run by Université Libre de Bruxelles at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory biological variables (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.