Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT01173432
Status:
COMPLETED
Last Update Posted:
2019-04-17
First Post:
2010-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploring the Role of Adipocyte Fatty Acid Binding Protein in the Association of Obstructive Sleep Apnea and Metabolic Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2010-07-29', 'studyFirstSubmitQcDate': '2010-07-30', 'lastUpdatePostDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adipocyte fatty acid binding protein', 'timeFrame': 'changes over 4 weeks of CPAP treatment', 'description': 'blood assay'}], 'secondaryOutcomes': [{'measure': 'Insulin and glucose', 'timeFrame': 'changes over 4 weeks of CPAP treatment', 'description': 'blood assay'}, {'measure': 'Lipids and lipoprotein', 'timeFrame': 'changes over 4 weeks of CPAP treatment', 'description': 'blood assay'}, {'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', 'description': 'by sleep questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['obstructive sleep apnea', 'metabolic dysfunction', 'metabolic syndrome', 'adipocyte fatty acid binding protein'], 'conditions': ['Obstructive Sleep Apnea', 'Insulin Resistance', 'Metabolic Syndrome', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '16423904', 'type': 'BACKGROUND', '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.'}, {'pmid': '16919044', 'type': 'BACKGROUND', '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.'}, {'pmid': '19181913', 'type': 'BACKGROUND', '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.'}, {'pmid': '31372823', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'We hypothesize that there are changes in circulating A-FABP level which can be mitigated by effective treatment of OSA.\n\nThe aim is to investigate the effect of CPAP treatment of OSA on circulating A-FABP, and other metabolic biomarkers and cardiovascular parameters'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects between 18 - 65 years old\n* Able to understand and give informed written consent\n\nExclusion Criteria:\n\n* BMI \\> 35 kg/m2, and features of obesity hypoventilation syndrome\n* known diabetes mellitus or hyperlipidemia on treatment\n* known cardiovascular disease except hypertension stable on treatment\n* unstable medical illness\n* need for starting treatment for OSA or other medical conditions immediately'}, 'identificationModule': {'nctId': 'NCT01173432', 'briefTitle': 'Exploring the Role of Adipocyte Fatty Acid Binding Protein in the Association of Obstructive Sleep Apnea and Metabolic Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'UW07-178'}, 'secondaryIdInfos': [{'id': 'HKCTR-770', 'type': 'REGISTRY', 'domain': 'Clinical trial centre, The University of Hong Kong'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'continuous positive airway pressure', 'description': 'using continuous positive airway pressure (CPAP) device during sleep, for the study period (4 weeks)', 'interventionNames': ['Device: continuous positive airway pressure']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'observation for the study period (4 weeks, no CPAP)'}], 'interventions': [{'name': 'continuous positive airway pressure', 'type': 'DEVICE', 'description': 'an device to be used during sleep, which was a nasal mask connected to a device with pressure applied to upper airway', 'armGroupLabels': ['continuous positive airway pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '852', 'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Mary SM Ip, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong, Queen Mary Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor Mary SM Ip', 'oldOrganization': 'The University of Hong Kong, Queen Mary Hospital'}}}}