Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2026-02-21 @ 9:53 PM
Study NCT ID:
NCT04024306
Status:
UNKNOWN
Last Update Posted:
2023-07-19
First Post:
2019-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Steroid-induced Diabetes Mellitus in Systemic Lupus Erythematosus (SLE) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-04-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2019-07-16', 'studyFirstSubmitQcDate': '2019-07-16', 'lastUpdatePostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who developed Steroid-induced diabetes mellitus', 'timeFrame': 'up to 12 months post-randomization', 'description': 'development of diabetes mellitus after corticosteroid therapy'}], 'secondaryOutcomes': [{'measure': "Number of patients who didn't develop steroid-induced diabetes mellitus", 'timeFrame': '12 months', 'description': 'no development of diabetes mellitus after corticosteroid therapy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['System; Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine the prevalence of steroid-induced diabetes mellitus (SDM) among systemic lupus erythematosus (SLE) patients and identify and assess the associated risk factors .', 'detailedDescription': '120 SLE patients who attend the SLE and Rheumatology Clinic will be recruited into the study. All patients need to fulfil at least four criteria from the American College of Rheumatology Classification Criteria for SLE 1997(28). All patients need to be receiving corticosteroid therapy. SDM cases is defined as the development of DM after commencement of steroid treatment. Prevalent cases of SDM will also be included in the study.\n\nDiagnosis of DM will be made according to the American Diabetes Association(29), that is fasting plasma glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5 or 2-h plasma glucose ≥ 11.1 mmol/L during an oral glucose tolerance test (OGTT). SLE patients who receive corticosteroids treatment will be screened with fasting blood sugar during out-patient clinic visit. If fasting blood glucose level is high , an additional HbA1C or OGTT will be performed.\n\nAll patients included in this study will be subjected to:\n\n1. Full history taking: including age, sex, duration of the SLE disease , age at onset of symptoms of SLE, the progression of disease, type of corticosteroid used, dosage, duration of treatment and other types of drugs used, presence of hypertension, dyslipidemia, smoking.\n2. Complete clinical examination: A standardized physical examination will be performed in all patients to measure blood pressure, waist circumference and body mass index.\n3. Laboratory investigations:\n\n * Fasting plasma glucose.\n * HbA1c.\n * 2-h plasma glucose.\n * Total cholesterol, triglyceride, low density lipoprotein (LDL) and high density lipoprotein (HDL) levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '120 SLE patients who attend the SLE and Rheumatology Clinic will be recruited into the study. All patients need to fulfil at least four criteria from the American College of Rheumatology Classification Criteria for SLE 1997(28). All patients need to be receiving corticosteroid therapy. SDM cases is defined as the development of DM after commencement of steroid treatment. Prevalent cases of SDM will also be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Both males and females\n* Patients aged of 18-75 years.\n* Clinically diagnosed as SLE patients.\n* Receiving corticosteroid therapy.\n* Prevalent cases of SDM with SLE.\n\nExclusion criteria\n\n* SLE patients who do not receive corticosteroid therapy.\n* SLE patients with other types of diabetes mellitus.'}, 'identificationModule': {'nctId': 'NCT04024306', 'briefTitle': 'Steroid-induced Diabetes Mellitus in Systemic Lupus Erythematosus (SLE) Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Steroid-induced Diabetes Mellitus in Systemic Lupus Erythematosus (SLE) Patients', 'orgStudyIdInfo': {'id': 'SDM in SLE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SLE with corticosteroid therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71511', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Dean of hospital', 'role': 'CONTACT', 'email': 'med@aun.edu.eg', 'phone': '20882411900'}, {'name': 'Muhammad Abd-Erazek Ahmad', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assiut university hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assiut, Egypt', 'investigatorFullName': 'Muhammad Abd-Erazek Ahmad', 'investigatorAffiliation': 'Assiut University'}}}}