[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypoglycemia-unawareness\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypoglycemia-unawareness":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100463650","early-phase-1-regulation-of-brain-glucose-metabolism-in-type-1-diabetes-100463650",false,"NCT05317455","Regulation of Brain Glucose Metabolism in Type 1 Diabetes","Inclusion Criteria:\n\nT1DM subjects with:\n\n* a history of severe hypoglycemia and\u002For hypoglycemia unawareness or\n* a history of severe hypoglycemia with a blood glucose \\\u003C54 mg\u002FdL, requiring the assistance of another person (with recovery after the administration of oral carbohydrate, intravenous glucose, or glucagon) or\n* at least 2 values \\\u003C54mg\u002Fdl during 2 weeks of CGMS testing during the week prior to study.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years or \\>55 years.\n* Body weight \\>85 kg at screening visit\n* BMI \\> 30 (female) and \\>30 (male) kg\u002Fm2.\n* Untreated proliferative retinopathy\n* carriers of glutathione transferase Z1 (GSTZ-1) gene polymorphisms that predispose to DCA accumulation and toxicity","ALL","18 Years","55 Years",{"count":19,"type":20},16,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","This is a prospective randomized placebo-controlled double-blind crossover pilot study determining the effect of dichloroacetate on brain function under clamped hypoglycemia in T1DM.",[26,27],"Diabetes Mellitus, Type 1","Hypoglycemia Unawareness","RECRUITING","2026-06-05",{"date":31,"type":32},"2026-06-09","ACTUAL",{"date":34,"type":32},"2025-05-13",{"date":36,"type":20},"2027-06-30",{"name":38,"class":39},"Yale University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":5},"100360254","phase-2-restoration-of-hypoglycemia-awareness-with-metoclopramide-100360254","NCT03970720","Restoration of Hypoglycemia Awareness With Metoclopramide","Inclusion Criteria:\n\n* Subjects with Type 1 Diabetes Mellitus\n* Diabetes duration \\> 5 years\n* Hemoglobin A1c ≤ 9%\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines\n\nExclusion Criteria:\n\n* History of myocardial infarction, cardiac arrhythmia, congestive heart failure and coronary artery insufficiency\n* History of stroke or brain disease\n* History of genitourinary obstruction or urinary retention\n* Advanced liver disease\n* Active anemia with hemoglobin less than 11 g\u002FdL\n* Female in pregnancy or breastfeeding, or not able to practice effective contraception during the study period\n* Uncontrolled mania or active major depressive disorder\n* Previous allergic reaction or side effect to heparin use\n* Contraindications to metoclopramide or conditions raising the risk for complication development to metoclopramide, such as hypersensitivity to metoclopramide, ongoing mechanical gastrointestinal obstruction, uncontrolled hypertension, pheochromocytoma, seizure disorders, Parkinson's disease, use of neuroleptics or antipsychotics within 6 months, use of benzodiazepines within the last month, active or recent (last 14 days) use of monoamine oxidase inhibitors or opioids, active alcohol or drug abuse, or other sedatives\n* Participation in another study evaluating treatment for impaired awareness of hypoglycemia or hypoglycemia-associated autonomic failure in the last 30 days\n* Current use of unblinded real-time Continuous Glucose Monitoring System\n* Frequent need of acetaminophen administration","20 Years","60 Years",{"count":50,"type":20},36,[52],"PHASE2","Metoclopramide is a drug approved by the FDA for gastroesophageal reflux and to relieve symptoms in adults with acute and recurrent diabetic gastroparesis. The objective of this study is to determine whether metoclopramide can improve hypoglycemia awareness and decrease the incidence of hypoglycemia in type 1 diabetes patients with hypoglycemia unawareness.",[27],[56],"Type 1 Diabetes Mellitus","2026-03-17",{"date":59,"type":32},"2026-03-20",{"date":61,"type":32},"2019-05-28",{"date":63,"type":20},"2027-12-31",{"name":65,"class":39},"Simon Fisher"]