Brain Glucose Metabolism in Type 1 Diabetes Study

This study is looking at how a medication called Dichloroacetate affects brain function in people with Type 1 Diabetes (T1D) who have experienced severe low blood sugar (hypoglycemia) or don't notice when their blood sugar is low (hypoglycemia unawareness). Researchers want to see if Dichloroacetate can help maintain your thinking skills when blood sugar is low. You might be able to join if you are between 18 and 55 years old, have T1D, and have a history of severe hypoglycemia or hypoglycemia unawareness. The study aims to see if Dichloroacetate can help the brain use glucose (sugar) better during low blood sugar events. The current status of this study is unclear.

Study design
This is a randomized, placebo-controlled, double-blind crossover pilot study with 16 planned participants. This means some participants will receive Dichloroacetate and others a placebo (inactive substance), and neither you nor the researchers will know which you are receiving.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your cognitive function will be measured at 1 day after the intervention.

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NCT05317455

Regulation of Brain Glucose Metabolism in Type 1 Diabetes

Recruiting
EARLY_PHASE1Ages 18–55InterventionalTreatment
Yale University
~16 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:Dichloroacetate

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cognitive Function
Measured over 1 day
Diabetes Mellitus, Type 1
Hypoglycemia Unawareness
1 sites across 1 states
Connecticut1
  • Raimund Herzog, MD · PRINCIPAL_INVESTIGATOR · Yale University

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • Cognitive Function1 day

    Measures of reaction time \[in milliseconds\] and cognitive testing performance under hypoglycemia \[percentage\].