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Prevalence of Obesity Hypoventilation Syndrome (BIO-OHS)

Primary Purpose

Obesity Hypoventilation Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood test analysis in the clinical labs
Pneumologist consult to establish the diagnosis of OHS
Sponsored by
AGIR à Dom
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obesity Hypoventilation Syndrome focused on measuring Obesity Hypoventilation Syndrome, Prevalence, Bicarbonate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cabinet de Pneumologie Grenoble SUD
  • Laboratoire MEDIBIO Les Cedres
  • Hôpital Michallon, Laboratoire EFCR et Sommeil
  • Cabinet de Pneumologie Perpignan
  • Laboratoire d'analyses medicales de Thuir

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

[HCO3-] >= 27 mmol/L (Group 1)

[HCO3-]< 27mmol/L+pneumologist (Group 2)

[HCO3-]< 27 mmol/L (Group 3)

Arm Description

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

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.

Obese patients with a [HCO3-]<27 mmol/L randomized to group 3 will receive usual medical follow-up (end of study)

Outcomes

Primary Outcome Measures

Prevalence of Obesity Hypoventilation Syndrome (OHS) in obese subjects referred to clinical laboratories for regular blood test analysis.
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
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
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
estimated by percentage
Incidence of serious health events at 1 and 2-year follow-up
Cardiovascular, metabolic and respiratory events (measured by percentages in OHS group and non-OHS group) will be compared by logistic regressions.

Full Information

First Posted
July 16, 2013
Last Updated
January 31, 2017
Sponsor
AGIR à Dom
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1. Study Identification

Unique Protocol Identification Number
NCT01903135
Brief Title
Prevalence of Obesity Hypoventilation Syndrome
Acronym
BIO-OHS
Official Title
Prevalence of Obesity Hypoventilation Syndrome in Subjects With Obesity Referred to Clinical (Medical Analysis) Laboratories for Regular Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AGIR à Dom

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
No additional description

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity Hypoventilation Syndrome
Keywords
Obesity Hypoventilation Syndrome, Prevalence, Bicarbonate

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1004 (Actual)

8. Arms, Groups, and Interventions

Arm Title
[HCO3-] >= 27 mmol/L (Group 1)
Arm Type
Other
Arm Description
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
Arm Title
[HCO3-]< 27mmol/L+pneumologist (Group 2)
Arm Type
Other
Arm Description
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.
Arm Title
[HCO3-]< 27 mmol/L (Group 3)
Arm Type
Other
Arm Description
Obese patients with a [HCO3-]<27 mmol/L randomized to group 3 will receive usual medical follow-up (end of study)
Intervention Type
Procedure
Intervention Name(s)
Blood test analysis in the clinical labs
Intervention Description
for specific measurement of plasmatic bicarbonate
Intervention Type
Procedure
Intervention Name(s)
Pneumologist consult to establish the diagnosis of OHS
Intervention Description
complete respiratory check-up: Arterial blood gases analysis, spirometry, anthropometry, polygraphy or polysomnography. Medical history, previous treatments.
Primary Outcome Measure Information:
Title
Prevalence of Obesity Hypoventilation Syndrome (OHS) in obese subjects referred to clinical laboratories for regular blood test analysis.
Description
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
Time Frame
From date of inclusion until the end of the study currently planned (up to 2 years)
Secondary Outcome Measure Information:
Title
Sensitivity and specificity of plasmatic [HCO3-] to detect OHS
Description
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.
Time Frame
From date of inclusion to the end of the study currently planned (2 years)
Title
Prevalence of metabolic and cardiovascular comorbidities in patients with OHS
Description
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.
Time Frame
From date of inclusion to the end of the study currently planned (2 years)
Title
To determine which medical specialties referred patients with OHS to clinical labs
Description
estimated by percentage
Time Frame
From date of inclusion to the end of the study currently planned (2 years)
Title
Incidence of serious health events at 1 and 2-year follow-up
Description
Cardiovascular, metabolic and respiratory events (measured by percentages in OHS group and non-OHS group) will be compared by logistic regressions.
Time Frame
From time of OHS diagnostic to 1 and 2-year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis Pepin, Pr, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cabinet de Pneumologie Grenoble SUD
City
Echirolles
Country
France
Facility Name
Laboratoire MEDIBIO Les Cedres
City
Echirolles
Country
France
Facility Name
Hôpital Michallon, Laboratoire EFCR et Sommeil
City
Grenoble
Country
France
Facility Name
Cabinet de Pneumologie Perpignan
City
Perpignan
Country
France
Facility Name
Laboratoire d'analyses medicales de Thuir
City
Thuir
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Prevalence of Obesity Hypoventilation Syndrome

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