Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-03-16 @ 12:38 AM
Study NCT ID:
NCT05851820
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2023-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Impact of Diabetes Mellitus in Hospitalized COVID-19 Patients in a Tunisian Center
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D003643', 'term': 'Death'}], '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': '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 866}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2023-05-05', 'studyFirstSubmitQcDate': '2023-05-08', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Admission to Intensive Care Units', 'timeFrame': '7 days', 'description': 'patients who were transferred to ICU'}, {'measure': 'death', 'timeFrame': '7 days', 'description': 'patients who were dead'}, {'measure': 'overall length of hospital stay', 'timeFrame': '7 days', 'description': 'length of hospital stay from admission to discharge (or transfer or death)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes mellitus', 'death', 'complications', 'COVID-19', 'SARS-CoV2', 'Intensive Care Units', 'Tunisia'], 'conditions': ['Prevalence', 'Diabetes Mellitus', 'Impaction', 'COVID-19']}, 'referencesModule': {'references': [{'pmid': '32267833', 'type': 'BACKGROUND', 'citation': 'Wang B, Li R, Lu Z, Huang Y. Does comorbidity increase the risk of patients with COVID-19: evidence from meta-analysis. Aging (Albany NY). 2020 Apr 8;12(7):6049-6057. doi: 10.18632/aging.103000. Epub 2020 Apr 8.'}, {'pmid': '32687793', 'type': 'BACKGROUND', 'citation': 'Apicella M, Campopiano MC, Mantuano M, Mazoni L, Coppelli A, Del Prato S. COVID-19 in people with diabetes: understanding the reasons for worse outcomes. Lancet Diabetes Endocrinol. 2020 Sep;8(9):782-792. doi: 10.1016/S2213-8587(20)30238-2. Epub 2020 Jul 17.'}, {'pmid': '16759303', 'type': 'BACKGROUND', 'citation': 'Yang JK, Feng Y, Yuan MY, Yuan SY, Fu HJ, Wu BY, Sun GZ, Yang GR, Zhang XL, Wang L, Xu X, Xu XP, Chan JC. Plasma glucose levels and diabetes are independent predictors for mortality and morbidity in patients with SARS. Diabet Med. 2006 Jun;23(6):623-8. doi: 10.1111/j.1464-5491.2006.01861.x.'}, {'pmid': '32496012', 'type': 'BACKGROUND', 'citation': 'Wu J, Zhang J, Sun X, Wang L, Xu Y, Zhang Y, Liu X, Dong C. Influence of diabetes mellitus on the severity and fatality of SARS-CoV-2 (COVID-19) infection. Diabetes Obes Metab. 2020 Oct;22(10):1907-1914. doi: 10.1111/dom.14105. Epub 2020 Jul 7.'}, {'pmid': '32683744', 'type': 'BACKGROUND', 'citation': 'Al-Salameh A, Lanoix JP, Bennis Y, Andrejak C, Brochot E, Deschasse G, Dupont H, Goeb V, Jaureguy M, Lion S, Maizel J, Moyet J, Vaysse B, Desailloud R, Ganry O, Schmit JL, Lalau JD. Characteristics and outcomes of COVID-19 in hospitalized patients with and without diabetes. Diabetes Metab Res Rev. 2021 Mar;37(3):e3388. doi: 10.1002/dmrr.3388. Epub 2020 Aug 18.'}]}, 'descriptionModule': {'briefSummary': 'Objective: The objective of this study was to evaluate the prevalence and impact of diabetes mellitus on the severity and mortality of COVID-19.\n\nMethods: Data of laboratory-confirmed hospitalized patients at the COVID-19 unit of Ibn El Jazzar University Hospital in Kairouan between September 2020 and August 2021 were analysed, in a cross-sectional study. The population was classified into two groups (COVID-19 patients with versus without diabetes). Primary outcomes were the overall length of hospital stay, the admission to the intensive care unit (ICU), and death.', 'detailedDescription': 'The outbreak of the coronavirus disease 2019 (Covid-19) has become an evolving worldwide health crisis. With the rising prevalence of diabetes mellitus has come an increasing awareness of their impacts on infectious diseases, and the risk for post-infection complications and mortality from critical infections.\n\nObjective: The objective of this study was to evaluate the prevalence and impact of diabetes mellitus on the severity and mortality of COVID-19.\n\nMethods: Data of laboratory-confirmed hospitalized patients at the COVID-19 unit of Ibn El Jazzar University Hospital in Kairouan between September 2020 and August 2021 were analysed, in a cross-sectional study. The population was classified into two groups (COVID-19 patients with versus without diabetes). Primary outcomes were the overall length of hospital stay, the admission to the intensive care unit (ICU), and death. Association between diabetes and death was assessed in a Cox proportional hazards model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Data collection is carried out from the medical records of patients using a standardized data collection form performed by the preventive medicine department of Ibn Al Jazzar's University Hospital. A trained team of family medicine residents accomplished the data collection. The variables included the following : Socio-demographic data, underlying comorbidities, symptoms and signs at admission, routine laboratory results, complications, treatment and outcomes.\n\nPatients were labelled as having diabetes mellitus if they were presently treated with insulin or oral hypoglycemic agents, and based on the patient's self-report on admission", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nConfirmed cases indicated the patients whose real-time reverse transcriptase-polymerase chain reaction (RT-PCR) analysis results for nasal swab specimens were positive.\n\nExclusion Criteria:\n\n* the investigators didn't included patients who were suspected cases, and whose the result of PCR test was negative ; Covid-19 patients admitted in other departments (Cardiology, pediatrics, obstetrics, intensive care unit, medicine, surgery department…) ; and patients with missing medical records. -"}, 'identificationModule': {'nctId': 'NCT05851820', 'briefTitle': 'Prevalence and Impact of Diabetes Mellitus in Hospitalized COVID-19 Patients in a Tunisian Center', 'organization': {'class': 'OTHER', 'fullName': 'Faculty of Medicine, Sousse'}, 'officialTitle': 'Prevalence and Impact of Diabetes Mellitus in Hospitalized COVID-19 Patients in a Tunisian Center: a Cross Sectional Study', 'orgStudyIdInfo': {'id': 'SRouis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'diabetic patients with COVID-19', 'description': 'patients hospitalized for COVID-19 and were diabetic', 'interventionNames': ['Other: comparison of outcomes/exposure']}, {'label': 'Non-diabetic patients with COVID-19', 'description': 'patients hospitalized for COVID-19 and were not diabetic', 'interventionNames': ['Other: comparison of outcomes/exposure']}], 'interventions': [{'name': 'comparison of outcomes/exposure', 'type': 'OTHER', 'description': 'analysing if diabetes mellitus have an impact on the primary outcomes: hospital stay, admission to the ICU, death.', 'armGroupLabels': ['Non-diabetic patients with COVID-19', 'diabetic patients with COVID-19']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kairouan', 'country': 'Tunisia', 'facility': 'Kairouan', 'geoPoint': {'lat': 35.6781, 'lon': 10.09633}}], 'overallOfficials': [{'name': 'sana rouis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Sousse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sana Rouis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant professor in Infectious Diseases', 'investigatorFullName': 'Sana Rouis', 'investigatorAffiliation': 'Faculty of Medicine, Sousse'}}}}