Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-03-02 @ 7:15 PM
Study NCT ID:
NCT06536933
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-05
First Post:
2024-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Metabolic Dysfunction-Associated Steatotic Liver Disease Among Sohag University Employees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-07-01', 'releaseDate': '2025-06-16'}], 'estimatedResultsFirstSubmitDate': '2025-06-16'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2024-07-31', 'studyFirstSubmitQcDate': '2024-07-31', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'waist circumference', 'timeFrame': '4 months', 'description': 'by using a flexible non-stretchable measuring tape by identifying measurement point midway between the lower margin of last palpable rib and the top of iliac crest.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Dysfunction-Associated Steatotic Liver Disease']}, 'referencesModule': {'references': [{'pmid': '37700494', 'type': 'BACKGROUND', 'citation': 'Chan WK, Chuah KH, Rajaram RB, Lim LL, Ratnasingam J, Vethakkan SR. Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A State-of-the-Art Review. J Obes Metab Syndr. 2023 Sep 30;32(3):197-213. doi: 10.7570/jomes23052. Epub 2023 Sep 13.'}, {'pmid': '30155850', 'type': 'BACKGROUND', 'citation': 'Inoue Y, Qin B, Poti J, Sokol R, Gordon-Larsen P. Epidemiology of Obesity in Adults: Latest Trends. Curr Obes Rep. 2018 Dec;7(4):276-288. doi: 10.1007/s13679-018-0317-8.'}, {'pmid': '28768170', 'type': 'BACKGROUND', 'citation': 'Stefan N, Schick F, Haring HU. Causes, Characteristics, and Consequences of Metabolically Unhealthy Normal Weight in Humans. Cell Metab. 2017 Aug 1;26(2):292-300. doi: 10.1016/j.cmet.2017.07.008.'}, {'pmid': '29333610', 'type': 'BACKGROUND', 'citation': 'Chan WK, Treeprasertsuk S, Imajo K, Nakajima A, Seki Y, Kasama K, Kakizaki S, Fan JG, Song MJ, Yoon SK, Dan YY, Lesmana L, Ho KY, Goh KL, Wong VW. Clinical features and treatment of nonalcoholic fatty liver disease across the Asia Pacific region-the GO ASIA initiative. Aliment Pharmacol Ther. 2018 Mar;47(6):816-825. doi: 10.1111/apt.14506. Epub 2018 Jan 14.'}]}, 'descriptionModule': {'briefSummary': '* Metabolic dysfunction-associated steatotic liver disease (MASLD) is the latest term for steatotic liver disease associated with metabolic syndrome. MASLD is a common cause of chronic liver disease and is the leading cause of liver-related morbidity and mortality.\n* The high prevalence of this disease has been fueled by the rapid rise in levels of sedentary behavior, low levels of physical activity, excess calorie intake relative to expenditure in nutritionally imbalanced and unhealthy diets. In parallel, the prevalence of poor metabolic health in adults from many countries is high, even in normal weight individuals.\n* MASLD has been estimated to affect 30% of the adult population worldwide, with its prevalence increasing from 22% to 37% from 1991 to 2019 . The increasing prevalence of MASLD parallels the increasing prevalence of obesity and obesity-related diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '100 Employees in Sohag University will be included in the study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 100 Employees in Sohag University will be included in the study.\n\nExclusion Criteria:\n\nEmployees with drug induced liver disease. Employees with chronic liver disease. Employees with decompensated liver cirrhosis. Employees with excessive alcohol consumption.'}, 'identificationModule': {'nctId': 'NCT06536933', 'briefTitle': 'Study of Metabolic Dysfunction-Associated Steatotic Liver Disease Among Sohag University Employees', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Study of Metabolic Dysfunction-Associated Steatotic Liver Disease Among Sohag University Employees', 'orgStudyIdInfo': {'id': 'Soh-Med-24-07-19MS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Abdominal Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnostic non invasive Abdomibal Ultrasound will be done to quantify hepatic steatosis'}]}, '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': 'Hossam Eldin H H, resident', 'role': 'CONTACT', 'email': 'hossamhamdy@med.sohag.edu.eg', 'phone': '01020678907'}, {'name': 'Ali T A, professor', 'role': 'CONTACT', 'phone': '01005871047'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident-Internal Medicine department-sohag hospital university', 'investigatorFullName': 'Hossam Eldin Hamdy Hamed', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-06-16', 'type': 'RELEASE'}, {'date': '2025-07-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hossam Eldin Hamdy Hamed, Resident-Internal Medicine department-sohag hospital university, Sohag University'}}}}