[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463650":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":37,"responsibleParty":58,"collaborators":35,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":35,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":35,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":35,"overallStatus":40,"whyStopped":35,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Yale University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","oral solution with flavoring agent, no active drug.",[13],"Drug: Dichloroacetate",{"label":15,"type":16,"description":17,"interventionNames":18},"Dichloroacetate","ACTIVE_COMPARATOR","oral solution of dichloroacetate with flavoring agent",[13],[20],{"type":21,"name":15,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Dichloroacetate has a long safety record of administration to humans with a rare metabolic disorder for over 40 years. It has been given orally to patients with T2DM for up to a week without any problems and other laboratory or significant clinical adverse effects were not noted. It activates mitochondrial PDH flux, a key regulator of glucose oxidation.",[15,9],[25],"DCA",[27],{"name":28,"affiliation":5,"role":29},"Raimund Herzog, MD","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Alice Hahn","CONTACT","4753210504",null,"alice.hahn@yale.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Yale-New Haven Hospital","RECRUITING","New Haven","Connecticut","06510","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-72.92816,41.30815,{"lat":50,"lon":49},[53,56],{"name":54,"role":33,"phone":55,"phoneExt":35,"email":36},"Alice Hahn Clinical Research Coordinator","5163052961",{"name":57,"role":29,"phone":35,"phoneExt":35,"email":35},"Raimund Herzog",{"type":29,"investigatorFullName":57,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Associate Professor of Medicine","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":70,"type":71},16,"ESTIMATED","INTERVENTIONAL",[74],"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.",[77,78],"Diabetes Mellitus, Type 1","Hypoglycemia Unawareness","2026-06-05",{"date":81,"type":82},"2026-06-09","ACTUAL",{"date":84,"type":82},"2025-05-13",{"date":86,"type":71},"2027-06-30",{"name":5,"class":6},1]