Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT03172650
Status:
UNKNOWN
Last Update Posted:
2017-08-16
First Post:
2017-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Non-alcoholic Fatty Liver Disease on Kidney Functions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005919', 'term': 'Glomerular Filtration Rate'}], 'ancestors': [{'id': 'D007677', 'term': 'Kidney Function Tests'}, {'id': 'D003950', 'term': 'Diagnostic Techniques, Urological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014553', 'term': 'Urinary Tract Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-13', 'studyFirstSubmitDate': '2017-05-30', 'studyFirstSubmitQcDate': '2017-05-30', 'lastUpdatePostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of patients with abnormal laboratory glomerular filtration rate', 'timeFrame': '1 day', 'description': 'decreased glomerular filtration rate \\<60 mL/minute will be considered abnormal'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Diseases']}, 'descriptionModule': {'briefSummary': 'Non-alcoholic fatty liver disease is the most common cause of chronic liver disease worldwide. It is defined as the accumulation of fat (\\>5%) in the liver cells in the absence of excessive alcohol intake or other causes of liver disease including viral, drug-induced, or autoimmune. Non-alcoholic fatty liver disease is a hepatic manifestation of metabolic syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited outpatient clinic of internal medicine of Luxor international hospital and Assiut university hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* All non alcoholic fatty liver disease patients evidenced by abdominal ultrasound.\n* Urine analysis whether normal or renal sedimentation.\n\nExclusion criteria:\n\n1. Alcoholic fatty liver patients.\n2. patients known to have diabetes mellitus.\n3. patients with other causes of liver disease as viral hepatitis, drug induced,or autoimmune.\n4. patients known to have kidney disease.\n5. Hypertension.\n6. Hyperuricemia.\n7. Impaired urea and creatinine patients.'}, 'identificationModule': {'nctId': 'NCT03172650', 'briefTitle': 'Effect of Non-alcoholic Fatty Liver Disease on Kidney Functions', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Non-alcoholic Fatty Liver Disease on Kidney Functions: Observational Case Control Study in Upper Egypt', 'orgStudyIdInfo': {'id': 'NAFLD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study group', 'description': 'non alcoholic fatty liver disease patients', 'interventionNames': ['Diagnostic Test: glomerular filtration rate']}, {'label': 'Control group', 'description': 'fatty liver patients', 'interventionNames': ['Diagnostic Test: glomerular filtration rate']}], 'interventions': [{'name': 'glomerular filtration rate', 'type': 'DIAGNOSTIC_TEST', 'description': 'collection of blood sample 5 milliliter for calculation of glomerular filtration rate', 'armGroupLabels': ['Control group', 'study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Assiut', 'state': 'Cairo Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ahmed abbas, MD', 'role': 'CONTACT', 'email': 'bmr90@hotmail.com'}, {'name': 'ahmed abbas', 'role': 'CONTACT'}], 'facility': 'Ahmed Abbas'}], 'centralContacts': [{'name': 'Mahmoud Ali, MBBCh', 'role': 'CONTACT', 'email': 'ans1111eg@gmail.com', 'phone': '00201144287363'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Ahmed Mohamed Abbas', 'investigatorAffiliation': 'Assiut University'}}}}