Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT06009250
Status:
UNKNOWN
Last Update Posted:
2023-08-24
First Post:
2023-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Non-alcoholic Fatty Liver Disease in Patients With Chronic Kidney Disease in Assiut
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-22', 'studyFirstSubmitDate': '2023-07-28', 'studyFirstSubmitQcDate': '2023-08-22', 'lastUpdatePostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'abdominal ultrasound', 'timeFrame': '1 year', 'description': 'assessment of Liver regarding fatty liver disease by Ultrasound.'}, {'measure': 'liver enzymes', 'timeFrame': '1 year', 'description': 'participants will undergo assessment of liver enzymes (AST and ALT) and results will be reporeted in a table.'}, {'measure': 'Fibroscan', 'timeFrame': '1 year', 'description': 'participants will undergo fibroscanning of the liver to assess NAFLD and results will be reported in a table.'}, {'measure': 'BUN, Cr level and estimated GFR', 'timeFrame': '1 year', 'description': 'participants will be assessed regarding BUN, CR and estimated GFR to confirm and follow up CKD patients involved in the study.'}, {'measure': 'Lipid Profile', 'timeFrame': '1 year', 'description': 'participants will be assessed regarding Cholesterol level, Triglycerides, HDL and LDL. results will be reported in a table'}, {'measure': 'Complete Blood Picture (WBCs, HB, Patelets', 'timeFrame': '1 year', 'description': 'total leucocytic count Hemoglobin level and platelet count will be assessed in our patients and will be reported in a table'}, {'measure': 'serum Uric Acid', 'timeFrame': '1 year', 'description': 'serum uric acid will be assessed and reported in our patients'}], 'secondaryOutcomes': [{'measure': 'Waist Circumference', 'timeFrame': '1 year', 'description': 'waist circumference measurement.'}, {'measure': 'Body Mass Index', 'timeFrame': '1 year', 'description': 'BMI will also be calculated.'}]}, 'conditionsModule': {'conditions': ['CKD', 'NAFLD']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to detect the prevalence of NAFLD in CKD patients\n\nThe main question\\[s\\] it aims to answer are:\n\n* \\[question 1\\] prevalence of NAFLD in CKD patients.\n* \\[question 2\\] the relationship between NAFLD and CKD.', 'detailedDescription': 'The goal of this observational study is to detect the prevalence of NAFLD in CKD patients\n\nThe main question\\[s\\] it aims to answer are:\n\n* \\[question 1\\] prevalence of NAFLD in CKD patients.\n* \\[question 2\\] the relationship between NAFLD and CKD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'CKD patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CKD patients\n\nExclusion Criteria:\n\n* HCV and HBV Positive patients\n* Alcoholics\n* patient on Hemodialysis\n* patients with wilson disease\n* patients with alpha one antitrypsin deficiency'}, 'identificationModule': {'nctId': 'NCT06009250', 'briefTitle': 'Prevalence of Non-alcoholic Fatty Liver Disease in Patients With Chronic Kidney Disease in Assiut', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Prevalence of Non-alcoholic Fatty Liver Disease in Patients With Chronic Kidney Disease in Assiut', 'orgStudyIdInfo': {'id': 'NAFLD and CKD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CKD patients', 'description': 'CKD patient who are not DM are investigated for the presence of NAFLD'}, {'label': 'normal control group', 'description': 'normal population are investigated to know the prevalence of NAFLD in contrast to patients with CKD.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muhammad Ameen Abdelrady Abdelaziz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Internal Medicine Resident', 'investigatorFullName': 'Muhammad Ameen Abdelrady Abdelaziz', 'investigatorAffiliation': 'Assiut University'}}}}