Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT05964751
Status:
UNKNOWN
Last Update Posted:
2023-07-28
First Post:
2023-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
the Association Between Metabolic Syndrome and Its Components With Lupus Nephritis in Systemic Lupus Erythematosus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-01-23', 'releaseDate': '2024-12-03'}], 'estimatedResultsFirstSubmitDate': '2024-12-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'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': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-26', 'studyFirstSubmitDate': '2023-07-18', 'studyFirstSubmitQcDate': '2023-07-26', 'lastUpdatePostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lipid profile (triglycerides)', 'timeFrame': '1 year', 'description': 'to detect triglycerides level as apart of diagnosis of metabolic syndrome'}, {'measure': 'blood pressure measurement', 'timeFrame': '1 year', 'description': 'to detect if patients is hypertinsive or not as apart of diagnosis of metaboic syndrome'}, {'measure': 'fasting blood suger', 'timeFrame': '1 year', 'description': 'measurment of fasting blood suger to detect hyperglycemia as apart of diagnosis of metaboic syndrome'}, {'measure': 'body mass index', 'timeFrame': '1 year', 'description': 'measurement of weight \\& height to detect body mass index as apart of diagnosis of metaboic syndrome'}, {'measure': 'protein creatinine ratio', 'timeFrame': '1 year', 'description': 'to measure amount of protein in urine as apart of lupus nephritis'}, {'measure': 'anti nuclear antibody test by IF', 'timeFrame': '1 YEAR', 'description': 'this test to diagnose patient as SLE'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lupus Nephritis']}, 'referencesModule': {'references': [{'pmid': '19136143', 'type': 'BACKGROUND', 'citation': 'Pons-Estel GJ, Alarcon GS, Scofield L, Reinlib L, Cooper GS. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthritis Rheum. 2010 Feb;39(4):257-68. doi: 10.1016/j.semarthrit.2008.10.007. Epub 2009 Jan 10.'}, {'pmid': '24504808', 'type': 'BACKGROUND', 'citation': 'Lim SS, Bayakly AR, Helmick CG, Gordon C, Easley KA, Drenkard C. The incidence and prevalence of systemic lupus erythematosus, 2002-2004: The Georgia Lupus Registry. Arthritis Rheumatol. 2014 Feb;66(2):357-68. doi: 10.1002/art.38239.'}, {'pmid': '14184513', 'type': 'BACKGROUND', 'citation': 'DUBOIS EL, TUFFANELLI DL. CLINICAL MANIFESTATIONS OF SYSTEMIC LUPUS ERYTHEMATOSUS. COMPUTER ANALYSIS OF 520 CASES. JAMA. 1964 Oct 12;190:104-11. doi: 10.1001/jama.1964.03070150014003. No abstract available.'}, {'pmid': '22556106', 'type': 'BACKGROUND', 'citation': 'Hahn BH, McMahon MA, Wilkinson A, Wallace WD, Daikh DI, Fitzgerald JD, Karpouzas GA, Merrill JT, Wallace DJ, Yazdany J, Ramsey-Goldman R, Singh K, Khalighi M, Choi SI, Gogia M, Kafaja S, Kamgar M, Lau C, Martin WJ, Parikh S, Peng J, Rastogi A, Chen W, Grossman JM; American College of Rheumatology. American College of Rheumatology guidelines for screening, treatment, and management of lupus nephritis. Arthritis Care Res (Hoboken). 2012 Jun;64(6):797-808. doi: 10.1002/acr.21664. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease that involve s many different organs and display a variable clinical course. The prevalence of SLE varies across gender, race/ethnicity, and geographic regions. SLE demonstrates a striking female predominance with a peak incidence of disease during the reproductive years. In adults, the female to male ratio is 10-15:1.\n\nClinical features in individual patients can be quite variable and range from mild joint and skin involvement to severe, life-threatening internal organ disease. Constitutional symptoms, rash, mucosal ulcers, inflammatory polyarthritis, photosensitivity, and serositis are the most common clinical features of the disease .\n\nMajor organ affection in SLE includes Neuropsychiatric involvement (cognitive impairment, depression, psychosis, seizures, stroke, demyelinating syndromes, peripheral neuropathy, etc.) and cardiopulmonary manifestations. Lupus nephritis is the most common of the potentially life-threatening manifestations .\n\nRenal involvement is common in SLE and is a significant cause of morbidity and mortality. It is estimated that as many as 90% of patients with SLE will have pathologic evidence of renal involvement on biopsy, but clinically significant nephritis will develop in only 50%.\n\nLupus involvement in the kidney manifests as urinary findings (proteinuria, hematuria, pathologic casts) with or without a rise in serum creatinine. The specific criteria listed for renal involvement are a urine protein \\> 500 mg/dL or red blood cell casts, Lupus nephritis is often confirmed by kidney biopsy, with the results showing one or more of the classes of lupus nephritis.\n\nThe metabolic syndrome is a prevalent disorder which is defined by the presence of central obesity, dyslipidemia, hypertension, and disturbed glucose metabolism . It is known that Metabolic syndrome predisposes to cardiovascular disease (CVD) and consequently, to a rise in CVD morbidity and mortality. This syndrome plays a major role in the complex network of systemic pro-inflammatory and prothrombotic states involved in the development of CVD .\n\nCompared with patients without Metabolic syndrome, SLE patients from the multinational, multiethnic Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) cohort with the diagnosis of Metabolic syndrome were older, had a higher disease activity, an increased number of recent disease flares, and had accrued more organ damage . Mok et al report that Metabolic syndrome is significantly associated with new organ damage, vascular events, and mortality in patients with SLE .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Age less than 18 years . Patient not able and willing to give written informed consent. Patients with pregnancy, cancer and with viral infectious diseases. Patients with other autoimmune diseases rather than SLE.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Age less than 18 years . 2. Patient not able and willing to give written informed consent. 3. Patients with pregnancy, cancer and with viral infectious diseases. 4. Patients with other autoimmune diseases rather than SLE.\n\nExclusion Criteria:\n\n* 1\\. Age less than 18 years . 2. Patient not able and willing to give written informed consent. 3. Patients with pregnancy, cancer and with viral infectious diseases. 4. Patients with other autoimmune diseases rather than SLE.'}, 'identificationModule': {'nctId': 'NCT05964751', 'briefTitle': 'the Association Between Metabolic Syndrome and Its Components With Lupus Nephritis in Systemic Lupus Erythematosus Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'the Association Between Metabolic Syndrome and Its Components With Lupus Nephritis in Systemic Lupus Erythematosus Patients', 'orgStudyIdInfo': {'id': 'soh-Med-23-07-15MS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patinets with lupus nephritis', 'description': 'patients diagnosed as lupus nehpritis', 'interventionNames': ['Diagnostic Test: lipid profile', 'Diagnostic Test: fasting blood suger']}, {'label': 'pathents without lupus nephritis', 'description': 'sle pathients not diagnosed as lupus nephritis', 'interventionNames': ['Diagnostic Test: lipid profile', 'Diagnostic Test: fasting blood suger']}, {'label': 'controls', 'description': 'controls will be matched for sex, age, and level of schooling withot history of connective tissue disorders, systemic active disease and renal history', 'interventionNames': ['Diagnostic Test: lipid profile', 'Diagnostic Test: fasting blood suger']}], 'interventions': [{'name': 'lipid profile', 'type': 'DIAGNOSTIC_TEST', 'description': 'measuerments of lipid profile parameters to detect hyperlipidemia', 'armGroupLabels': ['controls', 'pathents without lupus nephritis', 'patinets with lupus nephritis']}, {'name': 'fasting blood suger', 'type': 'DIAGNOSTIC_TEST', 'description': 'measurment of fasting blood suger to detect hyprerglicemia', 'armGroupLabels': ['controls', 'pathents without lupus nephritis', 'patinets with lupus nephritis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'contacts': [{'name': 'Magdy m Amin, professor', 'role': 'CONTACT'}], 'facility': 'Sohag university Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'mohamed s ali, resident', 'role': 'CONTACT', 'email': 'mohamedsalah@med.sohag.edu.eg', 'phone': '01015159035'}, {'name': 'sahar a al-rahman, assistant professor', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident at rheumatology and rehabilitation department', 'investigatorFullName': 'Mohamed Salah Eldin Ali', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-12-03', 'type': 'RELEASE'}, {'date': '2025-01-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mohamed Salah Eldin Ali, resident at rheumatology and rehabilitation department, Sohag University'}}}}