Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-27 @ 5:33 PM
Study NCT ID:
NCT01801150
Status:
COMPLETED
Last Update Posted:
2015-03-24
First Post:
2012-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CPAP in Diabetes Type 2 Patients With Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], '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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-19', 'studyFirstSubmitDate': '2012-11-16', 'studyFirstSubmitQcDate': '2013-02-26', 'lastUpdatePostDateStruct': {'date': '2015-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Impact of CPAP on glycemic control', 'timeFrame': '6 months', 'description': 'Analyze the impact of additional treatment with CPAP on serum lipids and C-reactive protein concentration in patients with type 2 diabetes and SAHS'}, {'measure': 'Quality of life after CPAP', 'timeFrame': '6 months', 'description': 'Establish the impact of additional treatment with CPAP on quality of life related to health of patients with type 2 diabetes and SAHS.'}, {'measure': 'Inflammatory markers after CPAP', 'timeFrame': '6 months', 'description': 'To evaluate the effect of CPAP on inflammatory cytokines, biomarkers of oxidative stress, sympathetic tone and intake regulating hormones in patients with type 2 diabetes and SAHS.'}, {'measure': 'Endocrine control with CPAP treatment', 'timeFrame': '6 months', 'description': 'Relate the CPAP-induced changes in the concentration of HbA1c and HOMA index with changes produced in the basal inflammatory reaction, oxidative stress, sympathetic activity and intake regulatory hormones.\n\nIdentify the subset of patients with poorly controlled type 2 diabetes and SAHS in the six months of treatment with CPAP achieve a more pronounced reduction in HbA1c.'}, {'measure': 'Influence of body distribution and activity on metabolic control', 'timeFrame': '6 months', 'description': 'To estimate the influence of the distribution of body mass and daily physical activity of patients with type 2 diabetes and SAHS on the metabolic response to treatment with CPAP.'}], 'primaryOutcomes': [{'measure': 'Glycemic control', 'timeFrame': 'Six months', 'description': 'To assess the effect of 6 months of CPAP therapy and conventional treatment on glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome (SAHS)'}], 'secondaryOutcomes': [{'measure': 'To determine additional effects of CPAP on insulin resistance in patients with type 2 diabetes and SAHS.', 'timeFrame': '6 months', 'description': '. Determine the medium term additional effect of CPAP on insulin resistance in patients with type 2 diabetes and SAHS.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Apnea- hypopnea Syndrome', 'Glycemic control', 'Prevalence', 'SAHS', 'life quality'], 'conditions': ['Diabetes', 'Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '26910598', 'type': 'DERIVED', 'citation': 'Martinez-Ceron E, Barquiel B, Bezos AM, Casitas R, Galera R, Garcia-Benito C, Hernanz A, Alonso-Fernandez A, Garcia-Rio F. Effect of Continuous Positive Airway Pressure on Glycemic Control in Patients with Obstructive Sleep Apnea and Type 2 Diabetes. A Randomized Clinical Trial. Am J Respir Crit Care Med. 2016 Aug 15;194(4):476-85. doi: 10.1164/rccm.201510-1942OC.'}]}, 'descriptionModule': {'briefSummary': 'Aim: To assess if six months of treatment with CPAP associated with conventional drug therapy, contribute to improved glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome SAHS)', 'detailedDescription': 'Main objective:\n\nTo assess the effect of 6 months of CPAP treatment associated with conventional drug therapy on glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome (SAHS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects 18 to 75 years old; diagnosis of type 2 diabetes mellitus; treatment with diet; oral antidiabetics or insulin stable in the last month; levels of HbA1c\\> 7.5% (if not supported clinic two controls to confirm with a difference not exceeding 0.5%); overweight or obese (BMI ≥ 25 kg/m2)\n\nExclusion Criteria:\n\n* professional drivers, risk profession or respiratory failure; excessive daytime sleepiness is very high (Epworth scale\\> 18); morbid obesity (BMI\\> 40 kg/m2); CPAP treatment'}, 'identificationModule': {'nctId': 'NCT01801150', 'acronym': 'DM-SAHS', 'briefTitle': 'CPAP in Diabetes Type 2 Patients With Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario La Paz'}, 'officialTitle': 'Effect Of Nasal CPAP On Glycemic Control In Patients With Poorly Controlled Type 2 Diabetes And Sleep Apnea-Hypopnea Syndrome', 'orgStudyIdInfo': {'id': 'HULP-DM-SAHS-2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'lifestyle and diabetes treatment', 'description': 'Counseil about lifestyle and current diabetes treatment'}, {'type': 'EXPERIMENTAL', 'label': 'CPAP nasal treatment', 'description': 'Continuous positive airway pressure (CPAP) nasal during the night and current diabetes treatment. Device', 'interventionNames': ['Device: CPAP nasal treatment']}], 'interventions': [{'name': 'CPAP nasal treatment', 'type': 'DEVICE', 'description': 'Treatment with titred CPAP nasal during the nighttime', 'armGroupLabels': ['CPAP nasal treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28046', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz- IdiPaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Francisco Garcia-Rio, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario La Paz, IdiPAZ'}, {'name': 'Elizabet Martínez-Cerón, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario La Paz, IdiPAZ'}, {'name': 'Alberto Alonso-Fernández, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Son Espasses'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Francisco Garcia-Rio', 'investigatorAffiliation': 'Hospital Universitario La Paz'}}}}