Prevalence of Obesity Hypoventilation Syndrome (BIO-OHS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by AGIR à Dom
Sponsor:
Information provided by (Responsible Party):
AGIR à Dom
ClinicalTrials.gov Identifier:
NCT01903135
First received: July 16, 2013
Last updated: March 27, 2014
Last verified: July 2013
  Purpose

Rationale of the "BIO-OHS" study (Prevalence of Obesity Hypoventilation Syndrome):

The overall prevalence of Obesity Hypoventilation Syndrome (OHS) has never been directly assessed in the general population. Actually, this prevalence has been assessed in patients referred to sleep clinics with a potential diagnosis of sleep-disordered breathing or in patients already diagnosed with sleep apnea. The purpose of this study is to determine the prevalence of Obesity Hypoventilation syndrome in obese patients referred to clinical laboratories for regular follow-up medical analysis.


Condition Intervention
Obesity Hypoventilation Syndrome
Procedure: Blood test analysis in the clinical labs
Procedure: Pneumologist consult to establish the diagnosis of OHS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prevalence of Obesity Hypoventilation Syndrome in Subjects With Obesity Referred to Clinical (Medical Analysis) Laboratories for Regular Follow-up

Resource links provided by NLM:


Further study details as provided by AGIR à Dom:

Primary Outcome Measures:
  • Prevalence of Obesity Hypoventilation Syndrome (OHS) in obese subjects referred to clinical laboratories for regular blood test analysis. [ Time Frame: From date of inclusion until the end of the study currently planned (up to 2 years) ] [ Designated as safety issue: No ]
    OHS prevalence, validated by arterial blood gases analysis, will be assessed by the percentage of patients with OHS among all patients included in the study


Secondary Outcome Measures:
  • Sensitivity and specificity of plasmatic [HCO3-] to detect OHS [ Time Frame: From date of inclusion to the end of the study currently planned (2 years) ] [ Designated as safety issue: No ]

    A ROC curve will determine if the threshold of 27 mmol/L has the best diagnostic value.

    Decision trees will show if the diagnostic value of plasmatic [HCO3-]could be optimized by a combination with other clinical parameters.


  • Prevalence of metabolic and cardiovascular comorbidities in patients with OHS [ Time Frame: From date of inclusion to the end of the study currently planned (2 years) ] [ Designated as safety issue: No ]
    Prevalence will be estimated by the percentage and the confidence interval. Prevalences of metabolic and cardiovascular comorbidities among patients with OHS and without OHS will be compared by a KHI-2 test or Fisher Exact depends on the theorical number.

  • To determine which medical specialties referred patients with OHS to clinical labs [ Time Frame: From date of inclusion to the end of the study currently planned (2 years) ] [ Designated as safety issue: No ]
    estimated by percentage

  • Incidence of serious health events at 1 and 2-year follow-up [ Time Frame: From time of OHS diagnostic to 1 and 2-year follow-up ] [ Designated as safety issue: No ]
    Cardiovascular, metabolic and respiratory events (measured by percentages in OHS group and non-OHS group) will be compared by logistic regressions.


Estimated Enrollment: 1000
Study Start Date: September 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
[HCO3-] >= 27 mmol/L (Group 1)
All obese patients with plasmatic[HCO3-] >= 27 mmol/L will be addressed to a pneumologist. The pneumology investigations will establish(or not) the diagnosis of OHS
Procedure: Blood test analysis in the clinical labs
for specific measurement of plasmatic bicarbonate
Procedure: Pneumologist consult to establish the diagnosis of OHS

complete respiratory check-up: Arterial blood gases analysis, spirometry, anthropometry, polygraphy or polysomnography.

Medical history, previous treatments.

[HCO3-]< 27mmol/L+pneumologist (Group 2)
Among obese patients with serum [HCO3-]< 27 mmol/L, 300 randomized patients will be addressed to a pneumologist. The pneumology investigations will refute(or not)the diagnosis of OHS.
Procedure: Blood test analysis in the clinical labs
for specific measurement of plasmatic bicarbonate
Procedure: Pneumologist consult to establish the diagnosis of OHS

complete respiratory check-up: Arterial blood gases analysis, spirometry, anthropometry, polygraphy or polysomnography.

Medical history, previous treatments.

[HCO3-]< 27 mmol/L (Group 3)
Obese patients with a [HCO3-]<27 mmol/L randomized to group 3 will receive usual medical follow-up (end of study)
Procedure: Blood test analysis in the clinical labs
for specific measurement of plasmatic bicarbonate

Detailed Description:

No additional description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years old ans more
  • BMI over 30 kg/M2
  • Stable state (respiratory, metabolic and cardio-vascular) for the last 2 months
  • Addressed to a clinical labs for a blood check-up whatever the prescription

Exclusion Criteria:

  • No social security
  • Non cooperative patient, as judged by the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01903135

Contacts
Contact: Jean Christian Borel, PhD j.borel@agiradom.com
Contact: Nellie Taleux, PhD n.taleux@agiradom.com

Locations
France
Cabinet de Pneumologie Grenoble SUD Recruiting
Echirolles, France
Contact: Nathalie Chrouri, MD       nchouri.pneumosud@orange.fr   
Principal Investigator: Nathalie Chouri, MD         
Sub-Investigator: Bruno Lepaulle, MD         
Sub-Investigator: Michel Jeanmart, MD         
Laboratoire MEDIBIO Les Cedres Recruiting
Echirolles, France
Contact: Guillaume Richallet, MD       guillaume.richalet@medibio.fr   
Principal Investigator: Guillaume Richalet, MD         
Hôpital Michallon, Laboratoire EFCR et Sommeil Recruiting
Grenoble, France
Contact: Jean Louis Pepin, Prof       JPepin@chu-grenoble.fr   
Sub-Investigator: Tamisier Renaud, MD-PhD         
Principal Investigator: Jean Louis Pepin, MD- PhD         
Sub-Investigator: Sandrine Launois-Rollinat, MD-PhD         
Cabinet de Pneumologie Perpignan Recruiting
Perpignan, France
Contact: Olivier Brun, MD       drbrunolivier@hotmail.com   
Principal Investigator: Olivier Brun, MD         
Laboratoire d'analyses medicales de Thuir Recruiting
Thuir, France
Contact: Philippe Schlouch, MD       phschlouch@biopole66.fr   
Principal Investigator: Philippe Schlouch, MD         
Sponsors and Collaborators
AGIR à Dom
Investigators
Principal Investigator: Jean-Louis Pepin, Pr, PhD University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: AGIR à Dom
ClinicalTrials.gov Identifier: NCT01903135     History of Changes
Other Study ID Numbers: 13-AGIR-02, 2013-A00744-41
Study First Received: July 16, 2013
Last Updated: March 27, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by AGIR à Dom:
Obesity Hypoventilation Syndrome
Prevalence
Bicarbonate

Additional relevant MeSH terms:
Obesity
Obesity Hypoventilation Syndrome
Syndrome
Hypoventilation
Respiratory Insufficiency
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014