Exploring the Role of Adipocyte Fatty Acid Binding Protein in the Association of Obstructive Sleep Apnea and Metabolic Dysfunction

Study Overview
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Brief Summary
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Adipocyte fatty acid binding protein (A-FABP) is a member of the FABP super family, is abundant in adipocytes and macrophages. Regulatory functions of A-FABP in lipid and glucose metabolism have been described, and it is suggested to play an important role in the pathogenesis of metabolic syndrome.We hypothesize that obstructive sleep apnea (OSA) may upregulate A-FABP production and thus causally contribute to metabolic dysfunction. Our group has recently demonstrated that A-FABP, expressed and secreted from adipocytes, is present in the blood stream .The levels of A-FABP correlated with various metabolic variates in the metabolic syndrome. Furthermore, we have obtained novel data in men with a range of sleep disordered breathing showed that the duration of oxygen desaturation correlated with circulating levels of A-FABP, independent of age and waist/body mass index. The current proposal aims to pursue this finding and further explore the role of A-FABP in the association of OSA and metabolic dysfunction.

Detailed Description
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We hypothesize that there are changes in circulating A-FABP level which can be mitigated by effective treatment of OSA. The aim is to investigate the effect of CPAP treatment of OSA on circulating A-FABP, and other metabolic biomarkers and cardiovascular parameters

Official Title
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Randomized Controlled Trial of the Effect of Continuous Positive Airway Pressure on Adipocyte Fatty Acid Binding Protein and Other Metabolic Markers in Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea, Insulin Resistance, Metabolic Syndrome, Inflammation

Intervention / Treatment
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* Device: continuous positive airway pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects between 18 - 65 years old Able to understand and give informed written consent Exclusion Criteria: BMI > 35 kg/m2, and features of obesity hypoventilation syndrome known diabetes mellitus or hyperlipidemia on treatment known cardiovascular disease except hypertension stable on treatment unstable medical illness need for starting treatment for OSA or other medical conditions immediately

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: continuous positive airway pressure<br>using continuous positive airway pressure (CPAP) device during sleep, for the study period (4 weeks) | Device: continuous positive airway pressure<br>* an device to be used during sleep, which was a nasal mask connected to a device with pressure applied to upper airway<br>|
| No Intervention: control<br>observation for the study period (4 weeks, no CPAP) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adipocyte fatty acid binding protein | blood assay | changes over 4 weeks of CPAP treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin and glucose | blood assay | changes over 4 weeks of CPAP treatment | 
| Lipids and lipoprotein | blood assay | changes over 4 weeks of CPAP treatment | 
| blood Markers of oxidative stress and fat metabolism |  | changes over 4 weeks of CPAP treatment | 
| blood inflammatory markers |  | changes over 4 weeks of CPAP treatment | 
| blood pressure |  | changes over 4 weeks of CPAP treatment | 
| Epworth sleepiness scale | by sleep questionnaire | changes over 4 weeks of CPAP treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, metabolic dysfunction, metabolic syndrome, adipocyte fatty acid binding protein