[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ketosis-prone-diabetes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ketosis-prone-diabetes":81},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":4,"eligibilityCriteria":13,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":20,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100569866",false,"NCT06699810","Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity","Inclusion Criteria:\n\n* Provide informed consent\n* Have a BMI ≥ 28 kg\u002Fm2\n* Be of African American ancestry\n* Meet diagnostic criteria for DKA. Diagnostic criteria for DKA will include a plasma glucose \\> 250 mg\u002Fdl, a venous pH \\\u003C 7.30, a serum bicarbonate \\\u003C 18 mmol\u002Fl, and serum ketones (beta-hydroxy butyrate) \\> 1.5 mmol\u002FL.\n\nExclusion Criteria:\n\n* Significant medical or surgical illness including but not limited to myocardial ischemia, congestive heart failure, chronic peripheral venous insufficiency, chronic renal insufficiency, liver insufficiency (serum transaminases 3 times the upper limit of normal) and acute or chronic infectious processes\n* Have recognized uncontrolled endocrine disorders such as hypercortisolism, acromegaly, or hyperthyroidism\n* Anemia (hemoglobin \\\u003C 12.5 g\u002FdL for men, \\\u003C11.5 gm\u002FdL for women), bleeding disorders, or abnormalities in coagulation studies\n* Pregnant\n* Diagnosis of diabetes \\> 90 days before the presentation of DKA\n* Unable to give consent","ALL","18 Years",{"count":17,"type":18},12,"ESTIMATED","INTERVENTIONAL",[21],"PHASE4","The goal of this study is to quantify day-to-day changes in blood glucose during treatment towards remission in ketosis-prone diabetes (KPDM) and describe them using a mathematical model of KPDM pathogenesis and remission.",[24],"Ketosis Prone Diabetes",[26,27],"diabetic ketoacidosis","type 2 diabetes","RECRUITING","2026-06-12",{"date":31,"type":32},"2026-06-15","ACTUAL",{"date":34,"type":32},"2025-01-23",{"date":36,"type":18},"2027-01",{"name":38,"class":39},"Emory University","OTHER",{"id":41,"slug":4,"hasResults":10,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":19,"phases":48,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"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.",{"count":47,"type":18},60,[49,50],"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.",[53,54,24,55],"Diabetes (DM)","Diabetic Ketoacidosis","Hyperglycaemia (Diabetic)",[57,58,59,60,61,62,63,64,65,66,67,68,69,70],"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":73,"type":32},"2026-02-12",{"date":75,"type":32},"2025-12-19",{"date":77,"type":18},"2027-12-31",{"name":79,"class":39},"David K Carroll",1,""]