Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-27 @ 11:17 PM
Study NCT ID:
NCT04561895
Status:
COMPLETED
Last Update Posted:
2020-09-24
First Post:
2020-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adipokine Genetic Variations in predictingNAFLD Progression to NASH in Egyptian Patients
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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}, 'targetDuration': '4 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-18', 'studyFirstSubmitDate': '2020-09-18', 'studyFirstSubmitQcDate': '2020-09-18', 'lastUpdatePostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'investigate adipokine dna polymorphism', 'timeFrame': '1 months', 'description': 'to investigate adipokine gene polymorphism associated with prognosis of NAFLD patients'}, {'measure': 'correlations', 'timeFrame': '1 month', 'description': 'to correlate between gene polymorphism and glycated hemoglobin, liver enzyme and obesity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Egyptian population', 'NAFLD', 'NASH', 'DNA extraction', 'liver enzymes'], 'conditions': ['NAFLD', 'NASH - Nonalcoholic Steatohepatitis']}, 'descriptionModule': {'briefSummary': 'Due to the limited data concerning Egyptian population. authors aimed to investigate the differentadipokine gene polymorphism related to non alcoholic fatty liver disease incidence, prognosis and progression to steotosis and also to find different related factors including obesitu, diabetes and liver enzymes level'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Egyptian diabetic patients diagnosed with NAFLD', 'eligibilityCriteria': "Inclusion Criteria:\n\nEgyptian patients confirmed NAFLD diagnosis diabetic\n\n\\-\n\nExclusion Criteria:\n\n* Pregnancy and lactation, history of alcohol abuse (as defined by an average daily consumption of alcohol \\> 30 g/day in men and \\> 20 g/day women), cirrhosis, autoimmune hepatitis and other causes of liver disease (viral hepatitis, hemochromatosis, Wilson's disease), drug induced hepatitis, chronic enteropathies, Chronic kidney disease"}, 'identificationModule': {'nctId': 'NCT04561895', 'briefTitle': 'Adipokine Genetic Variations in predictingNAFLD Progression to NASH in Egyptian Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Genetic Variations in Adipokine to Improve Risk Prediction for NAFLD and Its Progression to NASH in Egyptian Patients', 'orgStudyIdInfo': {'id': 'LC ElSahel'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control group', 'description': 'healthy volunteers with absence of NAFLD', 'interventionNames': ['Genetic: DNA extraction']}, {'label': 'test group', 'description': 'patients with confirmed NAFLD diagnosis', 'interventionNames': ['Genetic: DNA extraction']}], 'interventions': [{'name': 'DNA extraction', 'type': 'GENETIC', 'description': 'investigation of DNA polymorphism in patients suffering from NAFLD', 'armGroupLabels': ['control group', 'test group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11311', 'city': 'Cairo', 'state': 'Shobra', 'country': 'Egypt', 'facility': 'El Sahel teaching hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Amal Ahmed, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Elsahel teaching hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of pharmacology', 'investigatorFullName': 'Dalia K. Zaafar', 'investigatorAffiliation': 'Cairo University'}}}}