[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655047":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":27,"studyPopulation":28,"armGroups":29,"interventions":23,"overallOfficials":33,"centralContacts":38,"locations":23,"responsibleParty":44,"collaborators":23,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":23,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":61,"studyType":62,"phases":23,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":73,"whyStopped":23,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":79,"leadSponsor":81,"locationsCount":23},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Frequency of liver function test abnormalities","Proportion of children and adolescents with type 1 diabetes mellitus who have abnormal liver function tests (elevated ALT, AST, GGT, ALP, or bilirubin, or decreased albumin), expressed as percentage.","Baseline",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Pattern of LFT abnormalities","Characterization of LFT abnormality patterns (hepatocellular, cholestatic, mixed, or synthetic dysfunction)",{"measure":18,"description":19,"timeFrame":12},"Independent predictors of LFT abnormalities","Clinical and biochemical factors independently associated with abnormal liver function tests using multivariable logistic regression analysis.",{"measure":21,"description":22,"timeFrame":12},"Association with glycemic control","Comparison of LFT abnormalities between patients with good and poor glycemic control based on HbA1c levels.",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":25,"timePerspective":26,"maskingInfo":23},"CASE_ONLY","CROSS_SECTIONAL","Type 1 diabetes mellitus is associated with hepatic involvement, including glycogenic hepatopathy and metabolic dysfunction-associated steatotic liver disease. Liver function test abnormalities are reported in a significant proportion of pediatric patients with type 1 diabetes, yet data from Egypt remain limited.\n\nThis cross-sectional study will include children and adolescents aged 1 to 18 years with confirmed type 1 diabetes mellitus on insulin therapy. Clinical data, anthropometric measurements, and laboratory investigations including liver function tests will be collected. The study will determine the frequency and patterns of LFT abnormalities and identify independent clinical and biochemical predictors.","Children and adolescents aged 1 to 18 years with confirmed type 1 diabetes mellitus attending the Pediatric Endocrinology and Diabetes Clinic and Pediatric Wards of Assiut University Children Hospital.",[30],{"label":31,"type":23,"description":32,"interventionNames":23},"Single cohort: Children and adolescents with type 1 diabetes mellitus","Children and adolescents aged 1-18 years with confirmed type 1 diabetes mellitus on insulin therapy who will undergo clinical assessment and laboratory evaluation of liver function tests.",[34],{"name":35,"affiliation":36,"role":37},"Kotb A Metwalley, prof","pediatrics Department, Assiut University Hospitals","STUDY_CHAIR",[39],{"name":40,"role":41,"phone":42,"phoneExt":23,"email":43},"Hager R Mahmoud, Resident","CONTACT","+20 11 16532651","hagar.18313535@med.aun.edu.eg",{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Hager Raey Heshmat Mahmoud","Resident Physician","100655047","liver-function-test-abnormalities-in-pediatric-type-1-diabetes-100655047",false,"NCT07807553","Liver Function Test Abnormalities in Pediatric Type 1 Diabetes","Frequency, Pattern and Predictors of Liver Function Test Abnormalities in Children and Adolescents With Type 1 Diabetes Mellitus","Inclusion Criteria:\n\n* \\- Age 1 to 18 years\n* Confirmed type 1 diabetes mellitus on insulin therapy\n* Willingness of parents\u002Fguardians to provide informed consent\n\nExclusion Criteria:\n\n* \\- Pre-existing chronic liver disease\n* Type 2 diabetes mellitus\n* Acute systemic infections\n* Concurrent use of hepatotoxic medications","ALL","1 Year","18 Years",{"count":59,"type":60},101,"ESTIMATED","1 Day","OBSERVATIONAL","This cross-sectional study aims to determine the frequency, pattern, and predictors of liver function test abnormalities among children and adolescents with type 1 diabetes mellitus attending Assiut University Children Hospital.",[65,66],"Diabetes Mellitus, Type 1","Liver Diseases",[68,69,70,71,72],"Type 1 diabetes mellitus","Liver function tests","Adolescents","Children","Predictors","NOT_YET_RECRUITING","2026-09-02",{"date":76,"type":77},"2026-09-08","ACTUAL",{"date":74,"type":60},{"date":80,"type":60},"2028-06-01",{"name":5,"class":6}]