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NCT Number: NCT01173432

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Metabolic Syndrome Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong

Hong Kong, 852

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Positive Airway Pressure

Device

an device to be used during sleep, which was a nasal mask connected to a device with pressure applied to upper airway

Primary outcomes

  1. adipocyte fatty acid binding protein

    Time frame: changes over 4 weeks of CPAP treatment

    blood assay

Secondary outcomes

  1. Insulin and glucose

    Time frame: changes over 4 weeks of CPAP treatment

    blood assay

  2. Lipids and lipoprotein

    Time frame: changes over 4 weeks of CPAP treatment

    blood assay

  3. blood Markers of oxidative stress and fat metabolism

    Time frame: changes over 4 weeks of CPAP treatment

  4. blood inflammatory markers

    Time frame: changes over 4 weeks of CPAP treatment

  5. blood pressure

    Time frame: changes over 4 weeks of CPAP treatment

  6. Epworth sleepiness scale

    Time frame: changes over 4 weeks of CPAP treatment

    by sleep questionnaire

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
Aug 2, 2010
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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