Brain Ketone Metabolism in Type 1 Diabetes

Status Completed

Clinical Trial Summary

This study is designed to examine the value of infusing BHB in type 1 diabetic subjects during experimentally induced hypoglycemic episode in conjunction with testing of cognitive function. This will lay the basis for subsequent trials exploring the novel use of therapeutic doses of oral ketone formulations that are currently under commercial development, which could serve as adjunct therapies to protect the brain from hypoglycemia in type 1 diabetic subjects experiencing recurrent hypoglycemia.

Clinical Trial Description

Healthy controls as well as type 1 diabetic subjects will undergo a hyperinsulinemic-hypoglycemic clamp with concomitant BHB or saline (control) infusion in random order. During each experimental condition the participants will complete a battery of validated cognitive tests that are sensitive to the cognitive impairment typically caused by hypoglycemia. An additional healthy control arm was added to the study design after the initial registration as a 2 arm study, to provide imaging results of normal healthy responses to hypoglycemia. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02471040
Study type	Interventional
Source	Yale University
Contact
Status	Completed
Phase	Phase 1
Start date	May 14, 2013
Completion date	April 4, 2022

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