[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656141":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":34,"studyPopulation":35,"armGroups":36,"interventions":30,"overallOfficials":40,"centralContacts":45,"locations":30,"responsibleParty":51,"collaborators":30,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":30,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":30,"enrollmentInfo":64,"targetDuration":67,"studyType":68,"phases":30,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":79,"whyStopped":30,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":85,"leadSponsor":87,"locationsCount":30},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"DKA severity according to admission LGI","Proportion of patients with mild, moderate, and severe diabetic ketoacidosis according to admission Leukocyte Glucose Index (LGI) categories. LGI is calculated as leukocyte count (10³\u002FµL) × blood glucose (mg\u002FdL) \u002F 1000.","Baseline",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"Mean LGI according to DKA severity","Mean admission Leukocyte Glucose Index value in patients with mild, moderate, and severe diabetic ketoacidosis.",{"measure":18,"description":19,"timeFrame":12},"Prevalence of microvascular complications according to LGI","Proportion of patients with diabetic nephropathy, retinopathy, or peripheral neuropathy according to admission LGI categories.",{"measure":21,"description":22,"timeFrame":12},"Correlation of LGI with biochemical severity markers","Correlation coefficient between admission LGI and venous pH, serum bicarbonate, and anion gap, using Spearman or Pearson correlation as appropriate.",{"measure":24,"description":25,"timeFrame":12},"Discriminatory performance of LGI for severe DKA","Area under the ROC curve, sensitivity, and specificity of admission LGI for identifying severe diabetic ketoacidosis.",{"measure":27,"description":28,"timeFrame":29},"Hospital outcomes","Mean time to DKA resolution (hours) and length of hospital stay (days).","Up to 7 days",null,{"allocation":30,"interventionModel":30,"interventionModelDescription":30,"primaryPurpose":30,"observationalModel":32,"timePerspective":33,"maskingInfo":30},"COHORT","PROSPECTIVE","Diabetic ketoacidosis is a serious acute complication of diabetes. The Leukocyte Glucose Index (LGI), calculated from admission leukocyte count and blood glucose, is a simple biomarker that may help early risk stratification.\n\nThis observational study will include adult patients presenting with diabetic ketoacidosis. LGI will be calculated at admission. DKA severity will be classified as mild, moderate, or severe according to ADA criteria. Diabetic microvascular complications (nephropathy, retinopathy, and neuropathy) will be assessed.","Adult patients presenting with diabetic ketoacidosis to the Internal Medicine Department and Emergency Department of Assiut University Hospitals.",[37],{"label":38,"type":30,"description":39,"interventionNames":30},"Single cohort: Adults with diabetic ketoacidosis","Adult patients presenting with diabetic ketoacidosis who will have Leukocyte Glucose Index calculated at admission and will be assessed for DKA severity and microvascular complications.",[41],{"name":42,"affiliation":43,"role":44},"Mahmoud M Ashry, prof","Internal Medicine Department, Assiut University Hospitals","STUDY_CHAIR",[46],{"name":47,"role":48,"phone":49,"phoneExt":30,"email":50},"Heba H farag, Resident","CONTACT","01110892460","Heba.17289965@med.aun.edu.eg",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","heba helal farag","Resident Physician","100656141","leukocyte-glucose-index-and-severity-of-diabetic-ketoacidosis-100656141",false,"NCT07821814","Leukocyte Glucose Index and Severity of Diabetic Ketoacidosis","Elevated Leukocyte Glucose Index (LGI) and Severity of Diabetic Ketoacidosis and Microvascular Complications","Inclusion Criteria:\n\n* \\- Age 18 years or older\n* Known diabetes mellitus or newly diagnosed diabetes presenting with DKA\n* Fulfilling accepted clinical and biochemical diagnostic criteria for diabetic ketoacidosis\n* Written informed consent\n\nExclusion Criteria:\n\n* \\- Active infection or sepsis judged likely to substantially influence leukocyte count independently of DKA\n* Hematological malignancy or disorder affecting leukocyte count\n* Recent chemotherapy, G-CSF, or other treatment markedly altering leukocyte count\n* Pregnancy\n* Concurrent acute inflammatory or autoimmune disease likely to affect inflammatory indices\n* Systemic corticosteroid use before presentation when clinically significant\n* Incomplete clinical or laboratory data preventing LGI calculation or DKA severity assessment\n* Refusal to participate","ALL","18 Years",{"count":65,"type":66},120,"ESTIMATED","7 Days","OBSERVATIONAL","This prospective cohort study aims to evaluate the relationship between admission Leukocyte Glucose Index (LGI) and the severity of diabetic ketoacidosis, as well as the presence of diabetic microvascular complications, among adult patients at Assiut University Hospitals.",[71,72],"Diabetic Ketoacidosis","Diabetes Mellitus",[74,75,76,77,78],"Leukocyte Glucose Index","Diabetic ketoacidosis","LGI","DKA severity","Microvascular complications","NOT_YET_RECRUITING","2026-09-10",{"date":82,"type":83},"2026-09-16","ACTUAL",{"date":80,"type":66},{"date":86,"type":66},"2028-03-01",{"name":5,"class":6}]