[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-ketoacidosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-ketoacidosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,51,94,118,142,165,187],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100630146","biomarkers-of-acute-organ-injury-in-pediatric-newly-diagnosed-type-1-diabetes-100630146",false,"NCT07483879","Biomarkers of Acute Organ Injury in Pediatric Newly Diagnosed Type 1 Diabetes","Evaluation of Biomarkers and Clinical Parameters of Acute Organ Injury in Children With Newly Diagnosed Type 1 Diabetes: The Effect of Diabetic Ketoacidosis","Inclusion Criteria:\n\n* Children aged 2-16 years\n* Newly diagnosed type 1 diabetes mellitus\n* Hospital admission for initial evaluation and treatment\n* Presence or absence of diabetic ketoacidosis at diagnosis\n* Written informed consent from parents or legal guardians\n\nFor control group:\n\n\\- Age-matched healthy children without diabetes\n\nExclusion Criteria:\n\n* Previous diagnosis of diabetes mellitus\n* Known chronic kidney disease\n* Known cardiovascular disease\n* Acute infection or inflammatory condition unrelated to diabetes\n* Use of medications that may affect renal or cardiac biomarkers",true,"ALL","2 Years","16 Years",{"count":21,"type":22},45,"ESTIMATED","OBSERVATIONAL","Diabetic ketoacidosis (DKA) is a severe metabolic complication in children with newly diagnosed type 1 diabetes mellitus (T1DM) and may be associated with early injury of vital organs such as the kidneys and the heart. Early detection of organ dysfunction is important for identifying children at increased risk for complications.\n\nThis observational cross-sectional study aims to evaluate biomarkers of acute organ injury and associated clinical and echocardiographic parameters in children with newly diagnosed T1DM presenting with DKA, compared with children with newly diagnosed T1DM without DKA and healthy controls. Biomarkers including KIM-1, NGAL, high-sensitivity troponin, NT-proBNP, interleukin-6, and C-reactive protein will be measured during hospital admission and within the first 24-48 hours of hospitalization.",[26,27],"Type 1 Diabetes Mellitus","Diabetic Ketoacidosis",[29,30,31,32,33,34,35,36,37],"Biomarkers","Acute Kidney Injury","Cardiac Biomarkers","NGAL","NT-proBNP","hs-Troponin","Pediatric Type 1 Diabetes","Myocardial Strain Imaging","KIM-1","RECRUITING","2026-03-17",{"date":41,"type":42},"2026-03-19","ACTUAL",{"date":44,"type":42},"2025-06-13",{"date":46,"type":22},"2030-03",{"name":48,"class":49},"Aristotle University Of Thessaloniki","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":50},"100605835","phase-1-phase-1-trial-of-arginine-hydrochloride-for-the-management-of-diabetic-ketoacidosis-in-type-2-diabetes-100605835","NCT07167693","Phase 1 Trial of Arginine Hydrochloride for the Management of Diabetic Ketoacidosis in Type 2 Diabetes","Phase 1 Randomized Clinical Trial of Arginine Hydrochloride Administration to Reduce Duration of Diabetic Ketoacidosis in Patients With Type 2 Diabetes","Inclusion Criteria:\n\n* Age \\>17 years.\n* Unscheduled presentation to a participating emergency department with hyperglycemia (serum glucose \\>250 mg\u002FdL) and significant ketonemia consistent with DKA, defined as laboratory serum\u002Fplasma β-hydroxybutyrate (BHB) \\>20 mg\u002FdL (≈≥1.9 mmol\u002FL).\n\nNote: point-of-care capillary BHB ≥1.5 mmol\u002FL and\u002For breath acetone ≥0.01% may be used for screening while confirmatory labs are pending; if confirmatory BHB ≤20 mg\u002FdL, the participant is a screen failure.\n\n* Clinical phenotype consistent with ketosis-prone type 2 diabetes (no known prior diagnosis of type 1 diabetes).\n* Able to provide written informed consent and comply with study procedures in the ED.\n\nExclusion Criteria:\n\n* Current renal replacement therapy for chronic kidney disease (hemodialysis or peritoneal dialysis).\n* Known history of type 1 diabetes mellitus or known GAD65 autoantibody positivity.\n* Diagnosed cirrhosis\u002Fadvanced chronic liver disease.\n* Pregnancy (known pregnancy or positive test at screening).\n* Known allergy or hypersensitivity to arginine or its components.\n* Features of at least moderate acute alcohol intoxication at screening, per treating team.","18 Years",{"count":60,"type":22},60,"INTERVENTIONAL",[63,64],"PHASE1","PHASE2","Diabetic ketoacidosis (DKA) is increasingly recognized in adults with \"ketone-prone\" type 2 diabetes. In many of these patients, the pancreas can still make insulin but becomes temporarily \"stunned\" during severe, prolonged high blood sugar. Arginine is a naturally occurring amino acid that can trigger the pancreas to release its own insulin when glucose is high. It is FDA-approved for other uses and has been given intravenously for decades with a strong safety record. Whether a single arginine infusion given early during DKA can safely boost the body's insulin and speed recovery has not been tested.\n\nThis randomized, double-blind, placebo-controlled, phase 1\u002F2 trial will enroll 60 adults who present to one of four Detroit-area emergency departments with DKA consistent with ketone-prone type 2 diabetes (high glucose and significant ketones). Participants will receive standard DKA care ordered by their clinicians. In addition, under blinded conditions they will receive either arginine hydrochloride 30 grams (in 300 mL) or placebo (normal saline), infused intravenously over 30 minutes as early as feasible after DKA is recognized.\n\nThe main question is whether arginine increases endogenous (self-made) insulin soon after infusion. We will measure C-peptide (a marker released in equal amounts with insulin) and glucose at 10, 30, and 90 minutes after the start of the infusion and calculate the C-peptide\u002Fglucose ratio. Secondary measures include the rate of ketone (β-hydroxybutyrate) clearance and the total insulin dose required in the first 24 hours. Additional blood tests will examine arginine and related amino acids, and a small sample of platelets will be used to explore mitochondrial function. Safety will be closely monitored during and after the infusion, and participants will be contacted at 90 days to assess for any delayed problems.\n\nPotential risks include temporary flushing, nausea, or headache; the infusion can be stopped at any time if needed. Potential benefits include faster resolution of ketosis and reduced insulin needs, but benefits cannot be guaranteed for individual participants.",[67,27,68,69],"Diabetes (DM)","Ketosis Prone Diabetes","Hyperglycaemia (Diabetic)",[71,72,73,74,75,76,77,78,79,80,81,82,83,84],"Arginine hydrochloride","Arginine","R-Gene 10","Insulin secretagogue","Endogenous insulin secretion","C-peptide","C-peptide to glucose ratio","Type 2 ketosis-prone diabetes (T2KPD)","Flatbush diabetes","Ketosis-prone diabetes (KPD)","Hyperglycemic crisis","Nitric oxide (NO)","Global arginine bioavailability ratio (GABR)","Mitochondrial function","2026-02-09",{"date":87,"type":42},"2026-02-12",{"date":89,"type":42},"2025-12-19",{"date":91,"type":22},"2027-12-31",{"name":93,"class":49},"David K Carroll",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":50},"100607785","clinical-and-biological-signs-of-dapagliflozin-overdose-in-icu-patients-with-metformin-poisoning-100607785","NCT07193069","Clinical and Biological Signs of Dapagliflozin Overdose in ICU Patients With Metformin Poisoning","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Admission to an intensive care unit (ICU) due to acute drug poisoning\n* Documented exposure to either:\n* Metformin alone\n* Metformin in combination with dapagliflozin\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* No exposure to metformin\n* Exposure to dapagliflozin without metformin",{"count":101,"type":22},50,"This study looks at patients admitted to intensive care for drug poisoning involving metformin, a common diabetes medication. Researchers will compare two groups: patients who overdosed on metformin alone and those who took both metformin and dapagliflozin, another diabetes drug. The goal is to find clinical or laboratory signs that could help doctors quickly recognize a dapagliflozin overdose in this context, which could improve treatment and patient outcomes.",[104,105,106,107,27,108],"Drug Overdose","Metformin","Dapagliflozin","Lactic Acidosis","Intensive Care Units","2025-09-24",{"date":111,"type":42},"2025-09-25",{"date":113,"type":42},"2025-04-11",{"date":115,"type":22},"2026-04-11",{"name":117,"class":49},"Centre Hospitalier de Saint-Denis",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":61,"phases":128,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":141},"100497056","phase-3-balanced-multi-electrolyte-solution-versus-saline-trial-for-diabetic-ketoacidosis-100497056","NCT05752279","Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis","Balanced Multi-electrolyte Solution Versus 0.9% Sodium Chloride as Fluid Therapy for Patients Presenting With Moderate to Severe Diabetic Ketoacidosis","BEST-DKA","Inclusion Criteria:\n\n* Patients in the ED with a primary diagnosis of moderate to severe DKA for whom both saline and Plasma-Lyte® 148 are considered appropriate fluids\n* Blood glucose level \\> 14mmol\u002FL\n* pH \\\u003C 7.25\n* Serum bicarbonate \\\u003C15 mmol\u002FL\n* Elevated anion gap \\> 12mEq\u002FL\n* Ketones positive on finger prick measurements\n* In the judgement of the treating clinician critical care area admission is required\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Patients who have received more than 2000ml of non study fluid prior to study enrolment\n* Serum Na \\> 155 or \\\u003C120 mmol\u002FL\n* Contraindication to either study fluid e.g. previous allergic reaction to Plasma-Lyte® 148\n* Patients with hyperosmotic hyperglycaemic non-ketotic syndrome\n* Other clinical conditions that preclude large volumes of fluid resuscitation\n* Previous inclusion in BEST-DKA trial",{"count":127,"type":22},680,[129],"PHASE3","The goal of this blinded, cluster cross-over, randomised controlled trial is to determine whether fluid therapy with Plasma-Lyte® 148 increases the number of days alive and days out of hospital to day-28 compared to 0.9% sodium chloride ('0.9% saline') in critically ill patients presenting to the Emergency Department (ED) and deemed to require admission to a critical care area (ICU, HDU) with moderate to severe diabetic ketoacidosis (DKA).",[27],"2025-09-10",{"date":134,"type":42},"2025-09-17",{"date":136,"type":42},"2024-03-14",{"date":138,"type":22},"2026-07",{"name":140,"class":49},"The George Institute",21,{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":61,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":161,"locationsCount":164},"100589515","phase-2-reamberin-15-in-rehydration-therapy-of-diabetic-ketoacidosis-100589515","NCT06955416","REAMBERIN® 1.5% in Rehydration Therapy of Diabetic Ketoacidosis","A Multicenter, Randomized, Double-blind Study of the Safety and Efficacy of REAMBERIN®, 1.5% Solution for Infusions, in Addition to Standard Rehydration Therapy in Patients With Diabetic Ketoacidosis","Inclusion Criteria:\n\n* Signed Informed Consent\n* Male and female patients aged 18-75 years, inclusive.\n* Confirmed diagnosis of type 1 or type 2 diabetes mellitus\n* Established clinical diagnosis of DKA at the time of admission\n* Plasma glucose \\> 13.9 mmol \u002F l\n* Metabolic acidosis (venous blood pH \\\u003C 7.25)\n* Serum bicarbonate \\\u003C 18 mmol \u002F l\n* Ketonuria ≥ ++\n* Possibility of randomizing the patient within 2 hours from admission to the hospital.\n\nExclusion Criteria:\n\n* Known hypersensitivity to any component of the study drug\u002Fstandard therapy p\n* Blood pH ≤ 6.9 or standard bicarbonate level \\\u003C5 mmol\u002Fl\n* Previous use of other solutions containing reserve alkalinity carriers (acetate, lactate, malate, fumarate, etc).\n* Conditions requiring emergency surgical intervention\n* Abdominal surgeries in the last 14 days\n* Traumatic brain injury accompanied by cerebral edema.\n* Chronic treatment with steroids, atypical antipsychotics, cancer chemotherapy.\n* Acute kidney injury\n* Chronic kidney disease stage C5\n* Liver injury (increase in alanine aminotransferase (ALT), aspartate aminotransferase (AST) levels by more than 5 times the established reference values).\n* Acute pancreatitis\n* Sepsis\n* Severe multiple or combined trauma\n* History of malignancy\n* Clinically significant cardiovascular diseases (acute coronary syndrome; acute cerebrovascular accident (CVA) or transient ischemic attack (TIA); chronic heart failure class III - IV according to the NYHA classification; severe uncontrolled arrhythmia).\n* Body mass index \\>=40.0\n* Alcohol abuse, drug use, drug use.\n* Other specific types of diabetes mellitus.\n* Previously diagnosed mental illness\n* Participation in another clinical trial or the use of drugs\u002Fdietary supplements containing succinic acid less than 30 days before inclusion in this study.\n* Pregnancy or breastfeeding.\n* SARS-CoV-2 infection\n* Low systolic blood pressure (BP) (≤70 mmHg) upon admission to hospital or at the time of inclusion in the study.\n* Contraindications to the infusion of REAMBERIN of 0.9% sodium chloride solution.","75 Years",{"count":151,"type":22},312,[64,129],"A number of scientific papers have been published on the efficacy and safety of adding REAMBERIN® (meglumin sodium succinate), a 1.5% infusion solution, to standard therapy for patients with diabetic ketoacidosis (DKA), which showed that the addition of the medication to DKA therapy at a dose of 10 ml\u002Fkg\u002Fday or an average of 800.68±151.59 ml on the first day of infusion, leads to a more rapid and successful resolution of DKA, achieving a state of compensation, a more rapid transfer of the patient from the intensive care unit (ICU) and discharge from the hospital.\n\nA combined, two-stage, multicenter, randomized, double-blind, phase II\u002FIII study with an adaptive design is planned. Stage 1 (phase II) will be a sequential evaluation of 2 doses of the study medication (750 ml and 1500 ml) versus placebo. At the 2nd stage of the study (phase III), additional recruitment of patients will be carried out in two groups in a 1:1 ratio to the experimental group or placebo group, to receive the optimal dose in accordance with the result obtained at stage 1.",[27],"2025-06-18",{"date":157,"type":42},"2025-06-24",{"date":159,"type":42},"2025-05-01",{"date":91,"type":22},{"name":162,"class":163},"POLYSAN Scientific & Technological Pharmaceutical Company","INDUSTRY",3,{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":174,"conditions":175,"keywords":176,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":50},"100573598","serum-ferritin-and-prognosis-of-dka-100573598","NCT06748365","Serum Ferritin and Prognosis of DKA","Role of Ferritin in the Clinical Presentation and Short-Term Prognosis of Diabetic Ketoacidosis","Inclusion Criteria:\n\n\\-\n\nAll patients with DKA :\n\n1. Adult Aged 18 years old or older .\n2. Type 1 DM , type 2 DM\n3. Diagnosis of DKA based on the American Diabetes Association criteria: blood glucose \\>250 mg\u002FdL, arterial pH \\\u003C7.3, serum bicarbonate \\\u003C18 mEq\u002FL,\n\nExclusion Criteria:\n\n1. Patients age less than 18 years old\n2. Iron deficiency anemia and iron overload\n3. Chronic Inflammatory Diseases: Conditions such as rheumatoid arthritis, systemic lupus erythematosus, and inflammatory bowel disease\n4. Acute and chronic infections, including bacterial, viral, and fungal infections\n5. Pt presented with other acute complication (MI,stroke)\n6. CKD patients\n7. Patients with chronic liver diseases\n8. Patients with malignancy\n9. Pregnant women.",{"count":173,"type":22},100,"the aim of this study is to: evaluate the association between serum ferritin levels and the clinical presentation and short-term prognosis of patients with DKA. Specifically, the correlation between its level and the severity of DKA at presentation and determine its prognostic value in predicting short-term outcomes.",[27],[177,27],"serum Ferritin","2025-05-08",{"date":180,"type":42},"2025-05-14",{"date":182,"type":42},"2025-01-01",{"date":184,"type":22},"2026-02",{"name":186,"class":49},"Sohag University",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":17,"minAge":194,"maxAge":58,"enrollmentInfo":195,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":199,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":4},"100562133","children-with-diabetic-ketoacidosis-100562133","NCT06599203","Children with Diabetic Ketoacidosis","Prognostic Factors in Children with Diabetic Ketoacidosis","Inclusion Criteria:\n\nHospitalized diabetic patients aged from 1 year to 16 years with diabetic ketoacidosis\n\nExclusion Criteria:\n\n1. Other endocrine diseases as thyroid disease or pituitary disease\n2. Severe Hepatic Dysfunction or Chronic Kidney Dysfunction: Patients with significant liver or kidney impairment were excluded from the study.\n3. History of Malignant Tumor: The study did not include individuals with a previous history of any malignant tumor","1 Year",{"count":196,"type":22},130,"In the present work we aim to\n\n1. Response to therapy, During the management of DKA, acid base status, glycemia, and serum electrolytes are measured frequently to monitor the efficacy of treatment, detect complications of DKA and its treatment, and to determine resolution of DKA.\n2. Clinical complication like cerebral injury \u002F cerebral edema , cognitive impairment , acute kidney injury , hypokalemia.\n3. Severity of DKA",[27],"NOT_YET_RECRUITING","2024-09-13",{"date":202,"type":42},"2024-09-19",{"date":204,"type":22},"2024-10-01",{"date":206,"type":22},"2026-01-31",{"name":208,"class":49},"Assiut University"]