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NCT05317455 Clinical Trial

Regulation of Brain Glucose Metabolism in Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:
Regulation of Brain Glucose Metabolism in Type 1 Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05317455
Other study ID # Pending
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date January 2024
Est. completion date May 2024

Study information
Verified date October 2023
Source Yale University
Contact Alice Hahn
Phone 4753210504
Email alice.hahn@yale.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective randomized placebo-controlled double-blind crossover study determining the effect of dichloroacetate on brain glucose metabolism under clamped hypoglycemia in T1DM.

Description:

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 mechanistic study that determines whether brain metabolism is restored by this intervention, or whether the drug effect was primarily caused by changes in physiology outside of the brain.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 16
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• 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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Yale University

Outcome
Type Measure Description Time frame Safety issue
Primary PDH flux in the frontal lobe Neuronal PDH flux in the frontal lobe measured by DMI of labeled glucose 1 day
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