Regulation of Brain Glucose Metabolism in Type 1 Diabetes

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05317455
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Dichloroacetate — DRUG
    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.

Study Details

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 Dates

Start date
May 13, 2025
Status verified
Jun 2026
Primary completion
May 1, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    oral solution with flavoring agent, no active drug.
  • Active Comparator: Dichloroacetate
    oral solution of dichloroacetate with flavoring agent

Primary Outcome Measure

Cognitive Function [ Time Frame: 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale-New Haven HospitalNew HavenConnecticut06510
Alice Hahn Clinical Research Coordinator
[email protected]
5163052961
Raimund Herzog (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Yale-New Haven Hospital· New Haven, CT

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