Exploring the Role of Adipocyte Fatty Acid Binding Protein in the Association of Obstructive Sleep Apnea and Metabolic Dysfunction
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
2 other identifiers
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 29, 2010
CompletedFirst Posted
Study publicly available on registry
August 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedApril 17, 2019
April 1, 2019
10.5 years
July 29, 2010
April 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
adipocyte fatty acid binding protein
blood assay
changes over 4 weeks of CPAP treatment
Secondary Outcomes (6)
Insulin and glucose
changes over 4 weeks of CPAP treatment
Lipids and lipoprotein
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
- +1 more secondary outcomes
Study Arms (2)
continuous positive airway pressure
ACTIVE COMPARATORusing continuous positive airway pressure (CPAP) device during sleep, for the study period (4 weeks)
control
NO INTERVENTIONobservation for the study period (4 weeks, no CPAP)
Interventions
an device to be used during sleep, which was a nasal mask connected to a device with pressure applied to upper airway
Eligibility Criteria
You may qualify if:
- Subjects between 18 - 65 years old
- Able to understand and give informed written consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Hong Kong
Hong Kong, 852, Hong Kong
Related Publications (4)
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.
PMID: 16423904BACKGROUNDStejskal 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.
PMID: 16919044BACKGROUNDLam 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.
PMID: 19181913BACKGROUNDLui 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.
PMID: 31372823DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary SM Ip, MD
The University of Hong Kong, Queen Mary Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 29, 2010
First Posted
August 2, 2010
Study Start
June 1, 2008
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
April 17, 2019
Record last verified: 2019-04