Regulation of Brain Glucose Metabolism in Type 1 Diabetes

NCT05317455 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 2000035036
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Cognitive Function

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

  1 day

Secondary Outcomes (1)

• Brain glucose metabolism

  1 day

Study Arms (2)

Placebo

PLACEBO COMPARATOR

oral solution with flavoring agent, no active drug.

Drug: Dichloroacetate

Dichloroacetate

ACTIVE COMPARATOR

oral solution of dichloroacetate with flavoring agent

Drug: Dichloroacetate

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.

Also known as: DCA

Dichloroacetate; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Dichloroacetic Acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chloroacetates; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Raimund Herzog, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice Hahn

CONTACT

4753210504; alice.hahn@yale.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 7, 2022
• Study Start: May 13, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. For individual participant data meta-analysis

Locations

US (1)