Obesity-hypoventilation in Metabolic Syndrom Patients

Prevalence of Obesity-hypoventilation Syndrome in Patients With Metabolic Syndrome.

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

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome; Obesity Hypoventilation Syndrome; Capnography

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Delphine Delample, PhD; Phone Number: +33 0612155648; Email: d.delample@sosoxygene.com

Study Locations

• France
  • Bondigoux, France, 31340
    • Recruiting
    • Clinique du Château de Vernhes
    • Contact: Mathieu Despeaux, MD; Phone Number: +33 0561372727; Email: m.despeaux@cliniquevernhes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• obstructive respiratory disease
• non-treated cardiac dysfunction

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	body mass index	At the inclusion
Arterial pression in oxygen	PaO2	At the inclusion
Arterial blood bicarbonates	HCO3-	At the inclusion
Arterial blood gases	pH	At the inclusion
Hemoglobin	Hb	At the inclusion
obstructive sleep apnea items	Apnea-hypopnea index	Up to one mont after inclusion
Night Oxygen saturation	SpO2	Up to one mont after inclusion
somnolence	EPWORTH questionnaire; Minimum = 0; Maximum = 24, Higher score means a worth outcome	At the inclusion
Physical activity level	Ricci&Gagnon questionnaire, Minimum = 9; Maximum = 45, Higher score means a worth outcome	At the inclusion

Collaborators and Investigators

• Sponsor: SOS Oxygene Mediterranee
• Investigators: Principal Investigator: Mathieu Despeaux, MD, Clinique du Château de Vernhes

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms, Respiratory; Insulin Resistance; Hyperinsulinism; Sleep Apnea Syndromes; Respiratory Insufficiency; Sleep Apnea, Obstructive; Syndrome; Obesity; Metabolic Syndrome; Hypoventilation; Obesity Hypoventilation Syndrome
• Other Study ID Numbers: 2019-A02866-51

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No