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NCT05317455
Regulation of Brain Glucose Metabolism in Type 1 Diabetes
Conditions: Diabetes Mellitus, Type 1, Hypoglycemia Unawareness
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 16
Sponsor: Yale University
Location: Yale-New Haven Hospital New Haven Connecticut
Summary
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.
Eligibility Criteria
Inclusion Criteria:
T1DM subjects with:
* a history of severe hypoglycemia and/or hypoglycemia unawareness or
* a history of severe hypoglycemia with a blood glucose \85 kg at screening visit
* BMI \> 30 (female) and \>30 (male) kg/m2.
* Untreated proliferative retinopathy
* carriers of glutathione transferase Z1 (GSTZ-1) gene polymorphisms that predispose to DCA accumulation and toxicity
Source: ClinicalTrials.gov (NCT05317455). StuddyBuddy aggregates publicly available trial information.