Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT04779905
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
2021-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chronic Kidney Disease and Non-alcoholic Fatty Liver Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-01', 'studyFirstSubmitDate': '2021-02-26', 'studyFirstSubmitQcDate': '2021-02-26', 'lastUpdatePostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of chronic kidney disease in nafld patient', 'timeFrame': 'February 2021 to July 2021'}, {'measure': 'correlation of chronic kidney disease and degree of hepatic fibrosis in nafld patient', 'timeFrame': 'February 2021 to July 2021'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic kidney disease', 'NAFLD', 'Hepatic fibrosis'], 'conditions': ['Chronic Kidney Diseases', 'NAFLD']}, 'referencesModule': {'references': [{'pmid': '21623852', 'type': 'BACKGROUND', 'citation': 'Vernon G, Baranova A, Younossi ZM. Systematic review: the epidemiology and natural history of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in adults. Aliment Pharmacol Ther. 2011 Aug;34(3):274-85. doi: 10.1111/j.1365-2036.2011.04724.x. Epub 2011 May 30.'}, {'pmid': '22488764', 'type': 'BACKGROUND', 'citation': 'Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ. The diagnosis and management of non-alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012 Jun;55(6):2005-23. doi: 10.1002/hep.25762. No abstract available.'}, {'pmid': '24042449', 'type': 'BACKGROUND', 'citation': 'Loomba R, Sanyal AJ. The global NAFLD epidemic. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):686-90. doi: 10.1038/nrgastro.2013.171. Epub 2013 Sep 17.'}, {'pmid': '21965592', 'type': 'BACKGROUND', 'citation': 'McCullough K, Sharma P, Ali T, Khan I, Smith WC, MacLeod A, Black C. Measuring the population burden of chronic kidney disease: a systematic literature review of the estimated prevalence of impaired kidney function. Nephrol Dial Transplant. 2012 May;27(5):1812-21. doi: 10.1093/ndt/gfr547. Epub 2011 Sep 29.'}]}, 'descriptionModule': {'briefSummary': 'Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease worldwide. This disease reportedly affects up to 30% of the general population in Western countries, especially in patients with metabolic syndrome, obesity, and type II diabetes. NAFLD is considered to be an independent risk factor for cardiovascular disease and there is accumulating evidence to support a causative role in the development of chronic kidney disease (CKD). So, we aim first to assess the prevalence of chronic kidney disease in NAFLD patients, secondly to detect the association between hepatic fibrosis and CKD in NAFLD patients', 'detailedDescription': 'This study will be conducted on 100 patients 70 patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital, and A control group of 30 healthy volunteers who looks normal on ultrasonography from February 2021 to July 2021.\n\nMethods:\n\nAll included patients will be subjected to:\n\n1. Detailed history, complete general and systemic examination .\n2. BMI will be calculated as follow\n3. Abdominal Ultrasonography.\n4. Laboratory investigations:\n\n Fasting and post-prandial blood sugar Serum lipogram. Liver function tests. Serum creatinine, Albumin -creatinine Ratio.\n5. Calculation of estimated Glomerular Filtration Rate eGFR.\n6. Liver stiffness measurements to detect degree of fibrosis and measurement of the degree of steatosis using (Fibroscan)\n\nEthical considerations:\n\nThe study will be approved by The Ethical committee of Sohag Faculty of Medicine, Sohag University.\n\nThe study protocol will be adherent to practice guidelines of the World Medical Association Code of Ethics (Declaration of Helsinki).\n\nAfter explanation about the nature of the procedures, possible complications, benefits, and steps of the study, All patients will give a written informed consent for participating in the study, performing abdominal ultrasound, taking blood samples, performing fibroscan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study will be conducted on 100 patients 70 patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital, and A control group of 30 healthy volunteers who looks normal on ultrasonography from February 2021 to July 2021', 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital\n\nExclusion Criteria:\n\n1. Diabetic patients.\n2. Hypertensive patients.\n3. Other causes of chronic liver disease rather than NAFLD.'}, 'identificationModule': {'nctId': 'NCT04779905', 'acronym': 'NAFLD', 'briefTitle': 'Chronic Kidney Disease and Non-alcoholic Fatty Liver Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Assessment of Chronic Kidney Disease in Non Alcoholic Fatty Liver Disease(NAFLD) Patients', 'orgStudyIdInfo': {'id': 'Soh-Med-21-02-40'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-alcoholic Fatty Liver Diseases', 'description': 'patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital', 'interventionNames': ['Diagnostic Test: urinary albumbin/creatinine ratio']}, {'label': 'control', 'description': 'healthy volunteers who looks normal on ultrasonography', 'interventionNames': ['Diagnostic Test: urinary albumbin/creatinine ratio']}], 'interventions': [{'name': 'urinary albumbin/creatinine ratio', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['estimated glomerular filtration rate'], 'description': 'detection of microalbuminuria in nafld patients', 'armGroupLabels': ['Non-alcoholic Fatty Liver Diseases', 'control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Mona Mohammed Abdelrahman', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'overallOfficials': [{'name': 'Radwa Farag, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sohag University'}, {'name': 'Mohamed Amin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sohag University'}, {'name': 'Shimaa Hemdan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sohag University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mona Mohammed Abdelrhman', 'investigatorAffiliation': 'Sohag University'}}}}