Obesity-hypoventilation in Metabolic Syndrom Patients | NCT04839419

Studies
Obesity-hypoventilation in Metabolic Syndrom Patients

NCT04839419

Sponsor

SOS Oxygene Mediterranee

Status

Unknown status

Last Update Posted

Nov 28, 2023Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Metabolic Syndrome
Obesity Hypoventilation Syndrome
Capnography

Interventions

Not provided

Countries

France

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Actual

Primary Completion Date

Aug 1, 2025Estimated

Completion Date

Aug 1, 2025Estimated

First Submitted Date

Apr 1, 2021

First Submission Date that Met QC Criteria

Apr 6, 2021

First Posted Date

Apr 9, 2021Actual

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

Nov 21, 2023

Last Update Posted Date

Nov 28, 2023Actual

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 purpose of the study is to determined the prevalence of obesity-hypoventilation syndrome in patients with metabolic syndrom.

Detailed Description

After being informed about the study and potential risks, patient agreed to participate and undergo :

a functional respiratory exploration, an arterial blood gas analyze, and a polygraphy coupled with a capnography during the same night.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Capnia	Arterial pression in CO2 and transcutaneous pression in CO2	Up to one mont after inclusion
Arterial pression in CO2	PaCO2	At the inclusion

Secondary Outcomes

Measure	Description	Time Frame
BMI	body mass index	At the inclusion
Arterial pression in oxygen	PaO2	At the inclusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI>30 kg/m2
no treatment with CPAP nor NIV

Exclusion Criteria:

obstructive respiratory disease
non-treated cardiac dysfunction

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients will be selected as part of their usual care, during a consultation for their respiratory and metabolic monitoring.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Delphine Delample, PhD	Contact	0612155648	+33	d.delample@sosoxygene.com

Overall Officials

Name	Affiliation	Role
Mathieu Despeaux, MD	Clinique du Chateau de Vernhes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique du Château de Vernhes	Recruiting	Bondigoux		31340	France

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome
D010845	Obesity Hypoventilation Syndrome

Ancestor Terms

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided