Prevalence of Obesity Hypoventilation Syndrome

NCT01903135 | Completed

• 2 other identifiers: 13-AGIR-022013-A00744-41
• Study Type: interventional
• Target: 1,004
• Locations: 1 country
• Sites: 5

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.

Conditions

Obesity Hypoventilation Syndrome

Keywords

Obesity Hypoventilation Syndrome; Prevalence; Bicarbonate

Outcome Measures

Primary Outcomes (1)

• 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

  From date of inclusion until the end of the study currently planned (up to 2 years)

Secondary Outcomes (4)

• Sensitivity and specificity of plasmatic [HCO3-] to detect OHS

  From date of inclusion to the end of the study currently planned (2 years)

• Prevalence of metabolic and cardiovascular comorbidities in patients with OHS

  From date of inclusion to the end of the study currently planned (2 years)

• To determine which medical specialties referred patients with OHS to clinical labs

  From date of inclusion to the end of the study currently planned (2 years)

• Incidence of serious health events at 1 and 2-year follow-up

  From time of OHS diagnostic to 1 and 2-year follow-up

Study Arms (3)

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

OTHER

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; Procedure: Pneumologist consult to establish the diagnosis of OHS

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

OTHER

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; Procedure: Pneumologist consult to establish the diagnosis of OHS

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

OTHER

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

Interventions

Blood test analysis in the clinical labs PROCEDURE

for specific measurement of plasmatic bicarbonate

[HCO3-] >= 27 mmol/L (Group 1); [HCO3-]< 27 mmol/L (Group 3); [HCO3-]< 27mmol/L+pneumologist (Group 2)

Pneumologist consult to establish the diagnosis of OHS PROCEDURE

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

[HCO3-] >= 27 mmol/L (Group 1); [HCO3-]< 27mmol/L+pneumologist (Group 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No social security
• Non cooperative patient, as judged by the investigator

Sponsors & Collaborators

• AGIR à Dom: lead

Study Sites (5)

Cabinet de Pneumologie Grenoble SUD

Échirolles, France

Location

Laboratoire MEDIBIO Les Cedres

Échirolles, France

Location

Hôpital Michallon, Laboratoire EFCR et Sommeil

Grenoble, France

Location

Cabinet de Pneumologie Perpignan

Perpignan, France

Location

Laboratoire d'analyses medicales de Thuir

Thuir, France

Location

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Jean-Louis Pepin, Pr, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: July 19, 2013
• Study Start: September 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: February 1, 2017

Record last verified: 2015-03

Locations

FR (5)