Regulation of Brain Glucose Metabolism in Type 1 Diabetes

Recruiting now · Early Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 1, Hypoglycemia Unawareness

In brief

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.

Key facts

Study ID

NCT05317455

Run by

Yale University

People needed

16

Starts

2025-05-13

Expected to finish

2027-06-30

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Yale-New Haven Hospital — New Haven, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

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