Acute Effects of Propylene Glycol/Glycerol Intake on Bloo... | NCT03404011

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

NCT03404011

Sponsor

Université Libre de Bruxelles

Status

Completed

Last Update Posted

Apr 17, 2019Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Metabolic Complication

Interventions

Propylene glycol and Glycerol intake
Mimicking intake

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2018Actual

Primary Completion Date

Dec 30, 2018Actual

Completion Date

Dec 30, 2018Actual

First Submitted Date

Jan 11, 2018

First Submission Date that Met QC Criteria

Jan 18, 2018

First Posted Date

Jan 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2019

Last Update Posted Date

Apr 17, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Martin Chaumont, MD, Cardiology Fellow, Université Libre de BruxellesPrincipal Investigator

Lead Sponsor

Université Libre de BruxellesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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 :

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Propylene glycol and Glycerol intake	Experimental	One gram intake of a Propylene glycol/Glycerol mix (50:50)	Other: Propylene glycol and Glycerol intake
Mimicking intake	Placebo Comparator	Mimicking Propylene glycol/Glycerol intake with the device turns off	Device: Mimicking intake

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propylene glycol and Glycerol intake	Other	Intake of 1 gram of propylene glycol/Glycerol mix (50:50). Blood sample before, 5 minutes and 20 minutes after intake.	Propylene glycol and Glycerol intake

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiorespiratory biological variables	Blood sample	5 minutes

Secondary Outcomes

Measure	Description	Time Frame
Cardiorespiratory biological variables	Blood sample	20 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Chaumont, MD	Université Libre de Bruxelles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saint-Pierre Hospital		Brussels		1000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Data will be shared upon reasonnable request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jan 28, 2018	Mar 21, 2018	Prot_SAP_001.pdf

Intervention Browse Module

MeSH Terms

ID	Term
D019946	Propylene Glycol

Ancestor Terms

ID	Term
D011409	Propylene Glycols
D006018	Glycols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided