NCT01173432

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2010

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

10.5 years

First QC Date

July 29, 2010

Last Update Submit

April 16, 2019

Conditions

Keywords

obstructive sleep apneametabolic dysfunctionmetabolic syndromeadipocyte fatty acid binding protein

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 COMPARATOR

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

Device: continuous positive airway pressure

control

NO INTERVENTION

observation 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

continuous positive airway pressure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 16423904BACKGROUND
  • 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.

    PMID: 16919044BACKGROUND
  • 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.

    PMID: 19181913BACKGROUND
  • 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.

MeSH Terms

Conditions

Sleep Apnea, ObstructiveInsulin ResistanceMetabolic SyndromeInflammation

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Mary SM Ip, MD

    The University of Hong Kong, Queen Mary Hospital

    PRINCIPAL INVESTIGATOR

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

Locations