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Development of Agents to Diminish the Risk of Hypoglycemia-induced Brain Injury in Type 1 Diabetes

NCT03356457 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-01-22

No results posted yet for this study

Summary

To determine the effect of re-activation of brain glucose metabolism induced by dichloroacetate (DCA) on cognitive function and counterregulatory hormone responses in patients with type 1 diabetes (T1DM) with recurrent hypoglycemia.

Conditions

  • Hyperglycaemia (Diabetic)

Interventions

DRUG

Dichloroacetate

Dichloroacetate is an isoform-unspecific inhibitor of four regulatory pyruvate dehydrogenase kinases, which are able to reduce entry of substrates into mitochondria by reducing the conversion of pyruvate to acetyl-CoA. Drug will be administered to subjects with sever hypoglycemia as well as healthy non-diabetic subjects.

DRUG

Placebo oral capsule

A Placebo oral capsule identical in shape and color to those with active ingredient.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Raimund Herzog, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2019-03-20
Completion
2019-03-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03356457 on ClinicalTrials.gov