Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT04663659
Status:
COMPLETED
Last Update Posted:
2020-12-14
First Post:
2020-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Diabetes Mellitus on Mortality of Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2020-12-10', 'studyFirstSubmitQcDate': '2020-12-10', 'lastUpdatePostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '3 months', 'description': 'Mortality rates of patients'}, {'measure': 'length of stay in intensive care', 'timeFrame': '3 months', 'description': 'The time between admission to intensive care unit and discharge'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The study includes patients over 18 years old who were hospitalized in our covid intensive care unit between March 16 and May 16, 2020.\n\nRetrospective records were examined by examining the electronic data files of the patients.\n\nPolymerase Chain Reaction (PCR) tests performed with nasopharyngeal swab taken from the person, which is the standard diagnostic method, and also the diagnosis of infection symptoms, risk factors and thoracic CT scans indicating pneumonia were diagnosed.\n\nPatients over 18 years of age with and without a medical history of DM in their history were identified and compared in 2 groups.', 'detailedDescription': 'The study includes patients over 18 years old who were hospitalized in our covid intensive care unit between March 16 and May 16, 2020.\n\nRetrospective records will be examined by examining the electronic data files of the patients.\n\nPolymerase Chain Reaction (PCR) tests performed with nasopharyngeal swab taken from the person, which is the standard diagnostic method, and also the diagnosis of infection symptoms, risk factors and thoracic CT scans indicating pneumonia were diagnosed.\n\nPatients over 18 years of age with and without a medical history of DM in their history will be identified and compared in 2 groups.\n\nDemographic data such as age, gender, Body Mass Index (BMI) of all patients, presence of additional comorbid disease, blood glucose values during hospitalization in intensive care, ferritin, C-Reactive Protein (CRP), respiratory support methods (nasal oxygen, nasal high flow, non-invasive mechanical ventilation, intubation), length of stay in intensive care unit, and mortality will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 18 years of age with and without a medical history of DM in their history will be identified and compared in 2 groups', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients over 18 years of age\n\nExclusion Criteria:\n\n* Patients under 18 years of age'}, 'identificationModule': {'nctId': 'NCT04663659', 'briefTitle': 'The Effect of Diabetes Mellitus on Mortality of Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Sisli Hamidiye Etfal Training and Research Hospital'}, 'officialTitle': 'The Effect of Diabetes Mellitus on Mortality in Patients Hospitalized in the COVID Intensive Care Unit in the COVID-19 Pandemic', 'orgStudyIdInfo': {'id': '1559'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'diabetic group', 'description': 'Patients over the age of 18 with diabetes mellitus in intensive care unit', 'interventionNames': ['Other: no intervention']}, {'label': 'non-diabetic group', 'description': 'Patients over the age of 18 without diabetes mellitus in intensive care unit', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['diabetic group', 'non-diabetic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34771', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'SisliHamidiye Etfal Education and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Nermin Balta Basi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sisli Hamidiye Etfal Education and Training Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sisli Hamidiye Etfal Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical doctor', 'investigatorFullName': 'Nermin Balta Başı', 'investigatorAffiliation': 'Sisli Hamidiye Etfal Training and Research Hospital'}}}}