Regulation of Brain Glucose Metabolism in Type 1 Diabetes (NCT05317455) | Clinical Trial Compass
RecruitingEarly Phase 1
Regulation of Brain Glucose Metabolism in Type 1 Diabetes
United States16 participantsStarted 2025-05-13
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
T1DM subjects with:
* a history of severe hypoglycemia and/or hypoglycemia unawareness or
* a history of severe hypoglycemia with a blood glucose \<54 mg/dL, requiring the assistance of another person (with recovery after the administration of oral carbohydrate, intravenous glucose, or glucagon) or
* at least 2 values \<54mg/dl during 2 weeks of CGMS testing during the week prior to study.
Exclusion Criteria:
* Age \< 18 years or \>55 years.
* Body weight \>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