Regulation of Brain Glucose Metabolism in Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-13

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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

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Diabetes Mellitus, Type 1 Hypoglycemia Unawareness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Placebo

oral solution with flavoring agent, no active drug.

Group Type PLACEBO_COMPARATOR

Dichloroacetate

Intervention Type 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.

Dichloroacetate

oral solution of dichloroacetate with flavoring agent

Group Type ACTIVE_COMPARATOR

Dichloroacetate

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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DCA

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No