Regulation of Brain Glucose Metabolism in Type 1 Diabetes

Description

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

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Study Overview

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Study Details

Study overview

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.

Regulation of Brain Glucose Metabolism in Type 1 Diabetes

Regulation of Brain Glucose Metabolism in Type 1 Diabetes

Condition
Diabetes Mellitus, Type 1
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale-New Haven Hospital, New Haven, Connecticut, United States, 06510

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

Raimund Herzog, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

2026-06-30