NCT05317455

Regulation of Brain Glucose Metabolism in Type 1 Diabetes

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1
• Hypoglycemia Unawareness

Interventions

Type	Name	Description
DRUG	Dichloroacetate	Dichloroacetate has a long safety record of administration to humans with a rare metabolic disorder for over 40 years. It has been given orally to patients with T2DM for up to a week without any problems and other laboratory or significant clinical adverse effects were not noted. It activates mitochondrial PDH flux, a key regulator of glucose oxidation.

Timeline

• Start date: 2025-05-13
• Primary completion: 2026-05-01
• Completion: 2026-06-30
• First posted: 2022-04-07
• Last updated: 2025-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study