RecruitingEarly Phase 1NCT05317455

Regulation of Brain Glucose Metabolism in Type 1 Diabetes


Sponsor

Yale University

Enrollment

16 participants

Start Date

May 13, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study investigates how the brain uses glucose (sugar) in people with type 1 diabetes who experience dangerous low blood sugar episodes they don't feel coming (hypoglycemia unawareness). Brain glucose metabolism may be altered in these patients, causing them to lose the normal warning signs of low blood sugar. **You may be eligible if...** - You have type 1 diabetes - You have a history of severe low blood sugar episodes (requiring someone else's help to recover) and/or hypoglycemia unawareness - OR you had at least 2 blood sugar readings below 54 mg/dL during 2 weeks of continuous glucose monitoring **You may NOT be eligible if...** - You are under 18 or over 55 years old - Your body weight is over 85 kg - Your BMI is over 30 kg/m² - You have untreated severe eye disease (proliferative retinopathy) - You have certain genetic conditions or other complications that would interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDichloroacetate

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.


Locations(1)

Yale-New Haven Hospital

New Haven, Connecticut, United States

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NCT05317455


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