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Regulation of Brain Glucose Metabolism in Type 1 Diabetes

RECRUITINGEarly 1Sponsored by Yale University
Actively Recruiting
PhaseEarly 1
SponsorYale University
Started2025-05-13
Est. completion2026-05-01
Eligibility
Age18 Years – 55 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT05317455

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

Age: 18 Years – 55 YearsHealthy volunteers 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

Conditions3

DiabetesDiabetes Mellitus, Type 1Hypoglycemia Unawareness

Locations1 site

Yale-New Haven Hospital
New Haven, Connecticut, 06510
Alice Hahn Clinical Research Coordinator5163052961alice.hahn@yale.edu

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