Clinical trial NCT01173432: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Insulin Resistance
Metabolic Syndrome
Inflammation
Keywords: obstructive sleep apnea
metabolic dysfunction
metabolic syndrome
adipocyte fatty acid binding protein
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2010-08-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: adipocyte fatty acid binding protein
timeFrame: changes over 4 weeks of CPAP treatment
Secondary outcomes:
measure: Insulin and glucose
timeFrame: changes over 4 weeks of CPAP treatment
measure: Lipids and lipoprotein
timeFrame: changes over 4 weeks of CPAP treatment
measure: blood Markers of oxidative stress and fat metabolism
timeFrame: changes over 4 weeks of CPAP treatment
measure: blood inflammatory markers
timeFrame: changes over 4 weeks of CPAP treatment
measure: blood pressure
timeFrame: changes over 4 weeks of CPAP treatment
measure: Epworth sleepiness scale
timeFrame: changes over 4 weeks of CPAP treatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong, Queen Mary Hospital
name: Mary SM Ip, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.