Regulation of Brain Glucose Metabolism in Type 1 Diabetes

Trial ID: NCT05317455

Interventional - Phase 1 - Recruiting

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.

Conditions

• Diabetes Mellitus, Type 1
• Hypoglycemia Unawareness

Interventions

• Dichloroacetate

Eligibility

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

Sponsor

Yale University

Source: ClinicalTrials.gov

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