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

Primary Purpose

Obstructive Sleep Apnea, Insulin Resistance, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
continuous positive airway pressure
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, metabolic dysfunction, metabolic syndrome, adipocyte fatty acid binding protein

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

continuous positive airway pressure

control

Arm Description

using continuous positive airway pressure (CPAP) device during sleep, for the study period (4 weeks)

observation for the study period (4 weeks, no CPAP)

Outcomes

Primary Outcome Measures

adipocyte fatty acid binding protein
blood assay

Secondary Outcome Measures

Insulin and glucose
blood assay
Lipids and lipoprotein
blood assay
blood Markers of oxidative stress and fat metabolism
blood inflammatory markers
blood pressure
Epworth sleepiness scale
by sleep questionnaire

Full Information

First Posted
July 29, 2010
Last Updated
April 16, 2019
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01173432
Brief Title
Exploring the Role of Adipocyte Fatty Acid Binding Protein in the Association of Obstructive Sleep Apnea and Metabolic Dysfunction
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Insulin Resistance, Metabolic Syndrome, Inflammation
Keywords
obstructive sleep apnea, metabolic dysfunction, metabolic syndrome, adipocyte fatty acid binding protein

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
continuous positive airway pressure
Arm Type
Active Comparator
Arm Description
using continuous positive airway pressure (CPAP) device during sleep, for the study period (4 weeks)
Arm Title
control
Arm Type
No Intervention
Arm Description
observation for the study period (4 weeks, no CPAP)
Intervention Type
Device
Intervention Name(s)
continuous positive airway pressure
Intervention Description
an device to be used during sleep, which was a nasal mask connected to a device with pressure applied to upper airway
Primary Outcome Measure Information:
Title
adipocyte fatty acid binding protein
Description
blood assay
Time Frame
changes over 4 weeks of CPAP treatment
Secondary Outcome Measure Information:
Title
Insulin and glucose
Description
blood assay
Time Frame
changes over 4 weeks of CPAP treatment
Title
Lipids and lipoprotein
Description
blood assay
Time Frame
changes over 4 weeks of CPAP treatment
Title
blood Markers of oxidative stress and fat metabolism
Time Frame
changes over 4 weeks of CPAP treatment
Title
blood inflammatory markers
Time Frame
changes over 4 weeks of CPAP treatment
Title
blood pressure
Time Frame
changes over 4 weeks of CPAP treatment
Title
Epworth sleepiness scale
Description
by sleep questionnaire
Time Frame
changes over 4 weeks of CPAP treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary SM Ip, MD
Organizational Affiliation
The University of Hong Kong, Queen Mary Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
16423904
Citation
Xu A, Wang Y, Xu JY, Stejskal D, Tam S, Zhang J, Wat NM, Wong WK, Lam KS. Adipocyte fatty acid-binding protein is a plasma biomarker closely associated with obesity and metabolic syndrome. Clin Chem. 2006 Mar;52(3):405-13. doi: 10.1373/clinchem.2005.062463. Epub 2006 Jan 19.
Results Reference
background
PubMed Identifier
16919044
Citation
Stejskal D, Karpisek M. Adipocyte fatty acid binding protein in a Caucasian population: a new marker of metabolic syndrome? Eur J Clin Invest. 2006 Sep;36(9):621-5. doi: 10.1111/j.1365-2362.2006.01696.x.
Results Reference
background
PubMed Identifier
19181913
Citation
Lam DC, Xu A, Lam KS, Lam B, Lam JC, Lui MM, Ip MS. Serum adipocyte-fatty acid binding protein level is elevated in severe OSA and correlates with insulin resistance. Eur Respir J. 2009 Feb;33(2):346-51. doi: 10.1183/09031936.50075408.
Results Reference
background
PubMed Identifier
31372823
Citation
Lui MMS, Mak JCW, Chong PWC, Lam DCL, Ip MSM. Circulating adipocyte fatty acid-binding protein is reduced by continuous positive airway pressure treatment for obstructive sleep apnea-a randomized controlled study. Sleep Breath. 2020 Sep;24(3):817-824. doi: 10.1007/s11325-019-01893-5. Epub 2019 Aug 1.
Results Reference
derived

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

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