Recruiting
Early Phase 1

Observational Study

Sponsor:

Yale University

Code:

NCT05317455

Conditions

Diabetes Mellitus, Type 1

Hypoglycemia Unawareness

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Dichloroacetate

Study Details

Brief 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.

Conditions

Diabetes Mellitus, Type 1

Hypoglycemia Unawareness

Study ID

NCT05317455

Start date

May 13, 2025

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

oral solution with flavoring agent, no active drug.

active comparator: Dichloroacetate

oral solution of dichloroacetate with flavoring agent

Interventions

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.

Primary outcome measure

  • Cognitive Function [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Alice Hahn

4753210504alice.hahn@yale.edu

Locations

Yale-New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Alice Hahn Clinical Research Coordinator

5163052961alice.hahn@yale.edu

Principal Investigator:

Raimund Herzog

More Information

Sponsor

Yale University

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-09.