Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-01-24 @ 2:35 PM
Study NCT ID:
NCT02518633
Status:
COMPLETED
Last Update Posted:
2017-02-17
First Post:
2015-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obstructive Sleep Apnoea and Adipose Tissue Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D000860', 'term': 'Hypoxia'}], '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': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'adipose tissue and blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-16', 'studyFirstSubmitDate': '2015-03-23', 'studyFirstSubmitQcDate': '2015-08-05', 'lastUpdatePostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'adipose tissue gene expression of HIF-1alpha', 'timeFrame': '4 months', 'description': 'adipose tissue expression of hypoxia related genes'}], 'primaryOutcomes': [{'measure': 'pO2 in adipose tissue by Clarke type electrode', 'timeFrame': '4 months', 'description': 'Measurement of pO2 by Clarke type electrode'}], 'secondaryOutcomes': [{'measure': 'blood flow in adipose tissue by laser Doppler techniques', 'timeFrame': '4 months', 'description': 'assessment of tissue blood flow by laser Doppler techniques'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['obesity', 'hypoxia', 'adipose tissue'], 'conditions': ['Obstructive Sleep Apnoea', 'Obesity', 'Hypoxia']}, 'referencesModule': {'references': [{'pmid': '28131740', 'type': 'BACKGROUND', 'citation': 'Thorn CE, Knight B, Pastel E, McCulloch LJ, Patel B, Shore AC, Kos K. Adipose tissue is influenced by hypoxia of obstructive sleep apnea syndrome independent of obesity. Diabetes Metab. 2017 Jun;43(3):240-247. doi: 10.1016/j.diabet.2016.12.002. Epub 2017 Jan 26.'}]}, 'descriptionModule': {'briefSummary': "Dysfunctional adipose tissue predisposes to cardiovascular disease. Similarly, the risk of cardiovascular disease appears to be increased in subjects with obstructive sleep apnoea. Reduced adipose tissue oxygen availability has been described in obesity and may also be a mechanism in obstructive sleep apnoea. Hypoxia induces inflammation and fibrosis in adipose tissue which are factors contributing to cardiovascular risk. The investigators hypothesize that adipose tissue's oxygen uptake is reduced in subjects with obstructive sleep apnoea by comparing in vivo AT oxygenation and blood flow in tissue of control subjects.", 'detailedDescription': 'Assessment includes a adipose tissue biopsy and measurement of oxygenation and blood flow by a Clarke type electrodes and non-invasive Doppler techniques.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with newly diagnosed obstructive sleep apnoea and controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men with or without obstructive sleep apnoea\n\nExclusion Criteria:\n\n* weight loss interventions\n* steroid use\n* active smoking'}, 'identificationModule': {'nctId': 'NCT02518633', 'briefTitle': 'Obstructive Sleep Apnoea and Adipose Tissue Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Royal Devon and Exeter NHS Foundation Trust'}, 'officialTitle': 'Assessment of Hypoxia in Adipose Tissue of Subjects With Obstructive Sleep Apnoea', 'orgStudyIdInfo': {'id': 'OSAadipose'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'men with obstructive sleep apnoea', 'description': 'Continuous positive airway pressure devices', 'interventionNames': ['Device: Continuous positive airway pressure devices']}, {'label': 'control subjects', 'description': 'subjects with no obstructive sleep apnoea'}], 'interventions': [{'name': 'Continuous positive airway pressure devices', 'type': 'DEVICE', 'otherNames': ['CPAP'], 'description': 'overnight use of CPAP device', 'armGroupLabels': ['men with obstructive sleep apnoea']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EX25DW', 'city': 'Exeter', 'country': 'United Kingdom', 'facility': 'NIHR Clinical Research Facility', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'zip': 'EX25DW', 'city': 'Exeter', 'country': 'United Kingdom', 'facility': 'Royal Devon and Exeter NHS Foundation Trust', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}], 'overallOfficials': [{'name': 'Katarina Kos, FRCP,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Exeter'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Devon and Exeter NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Exeter', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Physician', 'investigatorFullName': 'Katarina Kos', 'investigatorAffiliation': 'Royal Devon and Exeter NHS Foundation Trust'}}}}