Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-01-04 @ 5:13 PM
Study NCT ID:
NCT03314467
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2017-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Obstructive Sleep Apnea Syndrome in the Occurrence of Diabetic Retinopathy in Type 2 Diabetes.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017286', 'term': 'Polysomnography'}, {'id': 'D062186', 'term': 'Arterial Pressure'}, {'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D001794', 'term': 'Blood Pressure'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'bloodserum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-01', 'studyFirstSubmitDate': '2017-10-16', 'studyFirstSubmitQcDate': '2017-10-16', 'lastUpdatePostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of obstructive sleep apnea in diabetic patients is a predictive factor for diabetic retinopathy occurence', 'timeFrame': '1 month', 'description': 'obstructive sleep apnea is defined as apnea-hypopnea index \\> 15 on polysomnography'}], 'secondaryOutcomes': [{'measure': 'Correlation between severity of obstructive sleep apnea and presence of diabetic retinopathy', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetic retinopathy', 'diabetes', 'arterial hypertension', 'obstructive sleep apnea syndrome'], 'conditions': ['Diabetes Mellitus', 'Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '28594570', 'type': 'BACKGROUND', 'citation': 'Altaf QA, Dodson P, Ali A, Raymond NT, Wharton H, Fellows H, Hampshire-Bancroft R, Shah M, Shepherd E, Miah J, Barnett AH, Tahrani AA. Obstructive Sleep Apnea and Retinopathy in Patients with Type 2 Diabetes. A Longitudinal Study. Am J Respir Crit Care Med. 2017 Oct 1;196(7):892-900. doi: 10.1164/rccm.201701-0175OC.'}, {'pmid': '28429032', 'type': 'BACKGROUND', 'citation': 'Mok Y, Tan CW, Wong HS, How CH, Tan KL, Hsu PP. Obstructive sleep apnoea and Type 2 diabetes mellitus: are they connected? Singapore Med J. 2017 Apr;58(4):179-183. doi: 10.11622/smedj.2017027.'}, {'pmid': '27990441', 'type': 'BACKGROUND', 'citation': 'Vujosevic S, Midena E. Diabetic Retinopathy in Italy: Epidemiology Data and Telemedicine Screening Programs. J Diabetes Res. 2016;2016:3627465. doi: 10.1155/2016/3627465. Epub 2016 Nov 21.'}, {'pmid': '28562529', 'type': 'BACKGROUND', 'citation': 'Zhou Y, Zhang Y, Shi K, Wang C. Body mass index and risk of diabetic retinopathy: A meta-analysis and systematic review. Medicine (Baltimore). 2017 Jun;96(22):e6754. doi: 10.1097/MD.0000000000006754.'}]}, 'descriptionModule': {'briefSummary': 'Diabetic retinopathy (DR) is the most common visual complication of diabetes. Risk factors for developing DR are diabetes duration, glycemic control, and hypertension . The prevalence ranges from 17 to 61% according to the diabetes duration .\n\nObstructive sleep apnea syndrome (OSAS) is very frequent in Type 2 Diabetes population, reaching a prevalence of 23-48% .\n\nFew is known about the exact role of OSAS in the development of DR. A recent study has shown that OSAS is an independent predictor for the progression to pre-/proliferative DR. The purpose of the present study is to assess if the presence of OSA in diabetic patients is a predictive factor for DR occurrence.', 'detailedDescription': 'Diabetic retinopathy (DR) is the most common visual complication of diabetes. Risk factors for developing DR are diabetes duration, glycemic control, and hypertension. The prevalence ranges from 17 to 61% according to the diabetes duration.\n\nObstructive sleep apnea syndrome (OSAS) is very frequent in Type 2 Diabetes population, reaching a prevalence of 23-48%.\n\nFew is known about the exact role of OSAS in the development of DR. A recent study has shown that OSAS is an independent predictor for the progression to pre-/proliferative DR. The purpose of the present study is to assess if the presence of OSA in diabetic patients is a predictive factor for DR occurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with a diagnosis of diabetes type I or type II who went to a ocular screening visit to assess ocular complications associated with diabetes are asked to undergo an in-lab polysomnography..', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presence of diabetic type II\n* able to undergo an in-lab polysomnography\n\nExclusion Criteria:\n\n* known presence of obstructive sleep apnea and treated by CPAP'}, 'identificationModule': {'nctId': 'NCT03314467', 'briefTitle': 'Role of Obstructive Sleep Apnea Syndrome in the Occurrence of Diabetic Retinopathy in Type 2 Diabetes.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Saint Pierre'}, 'officialTitle': 'Role of Obstructive Sleep Apnea Syndrome in the Occurrence of Diabetic Retinopathy in Type 2 Diabetes.', 'orgStudyIdInfo': {'id': 'BE76201733442'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases DR', 'description': 'diabetic patients with diabetic retinopathy (DR)', 'interventionNames': ['Diagnostic Test: polysomnography']}, {'label': 'Cases other', 'description': 'diabetic patiens with other/multiple ocular disorder(s)', 'interventionNames': ['Diagnostic Test: polysomnography']}, {'label': 'Control', 'description': 'diabetic patients without ocular abnormalities', 'interventionNames': ['Diagnostic Test: polysomnography']}], 'interventions': [{'name': 'polysomnography', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['arterial tension', 'blood test'], 'description': '* classical polysomnography\n* non invasive measurement of blood pressure\n* blood test: determination of HbA1c, glucose, C-peptide, hemoglobin, white blood cell count, trombocytes', 'armGroupLabels': ['Cases DR', 'Cases other', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': 'Centre Hospitalier Universitaire Saint Pièrre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Marie Bruyneel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre hospitalier universitaire St Pièrre - Pneumologie/Labo du sommeil'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Saint Pierre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chef de clinique', 'investigatorFullName': 'Marie Bruyneel', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Saint Pierre'}}}}