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

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01173432
• Other study ID #: UW07-178
• Secondary ID: HKCTR-770
• Status: Completed
• Phase: N/A
• Start date: June 2008
• Est. completion date: December 2018

Study information

• Verified date: April 2019
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Inflammation
• Insulin Resistance
• Metabolic Syndrome
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• continuous positive airway pressure
an device to be used during sleep, which was a nasal mask connected to a device with pressure applied to upper airway

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (3)

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. — View 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. — View 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. Epub 2006 Jan 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adipocyte fatty acid binding protein	blood assay	changes over 4 weeks of CPAP treatment
Secondary	Insulin and glucose	blood assay	changes over 4 weeks of CPAP treatment
Secondary	Lipids and lipoprotein	blood assay	changes over 4 weeks of CPAP treatment
Secondary	blood Markers of oxidative stress and fat metabolism		changes over 4 weeks of CPAP treatment
Secondary	blood inflammatory markers		changes over 4 weeks of CPAP treatment
Secondary	blood pressure		changes over 4 weeks of CPAP treatment
Secondary	Epworth sleepiness scale	by sleep questionnaire	changes over 4 weeks of CPAP treatment