NCT05317455EARLY_PHASE1Recruiting

Regulation of Brain Glucose Metabolism in Type 1 Diabetes

Yale University

Start Date

5/13/2025

Completion Date

6/30/2027

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.

Detailed Description

This study is a prospective randomized placebo-controlled double-blind crossover study designed to address the hypothesis that dichloroacetate has the ability to re-activate brain glucose metabolism under clamped hypoglycemia. The study population is comprised of intensively treated persons with T1D with frequent exposure to hypoglycemia, who have cognitive deficits under hypoglycemia that could be attributed to changes in brain glucose oxidation. The investigators will test the experimental compound DCA in a study that determines whether restoring brain glucose metabolism under hypoglycemia helps maintain cognitive function.

Eligibility Criteria

Age Range: 18 years to 55 years

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

Interventions

DRUG

Dichloroacetate

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Conditions

Diabetes Mellitus, Type 1Hypoglycemia Unawareness

Locations

Yale-New Haven Hospital

New Haven, Connecticut 06510

United States