[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463650":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":37,"responsibleParty":57,"collaborators":35,"id":59,"slug":35,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":35,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":35,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":35,"overallStatus":40,"whyStopped":35,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"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,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Yale-New Haven Hospital","RECRUITING","New Haven","Connecticut","06510","United States",{"type":46,"coordinates":47},"Point",[48,49],-72.92816,41.30815,{"lat":49,"lon":48},[52,55],{"name":53,"role":33,"phone":54,"phoneExt":35,"email":36},"Alice Hahn Clinical Research Coordinator","5163052961",{"name":56,"role":29,"phone":35,"phoneExt":35,"email":35},"Raimund Herzog",{"type":29,"investigatorFullName":56,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Associate Professor of Medicine","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":68,"type":69},16,"ESTIMATED","INTERVENTIONAL",[72],"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.",[75,76],"Diabetes Mellitus, Type 1","Hypoglycemia Unawareness","2026-06-05",{"date":79,"type":80},"2026-06-09","ACTUAL",{"date":82,"type":80},"2025-05-13",{"date":84,"type":69},"2027-06-30",{"name":5,"class":6},1]