Brain Ketone Metabolism in Type 1 Diabetes

Conditions:Endocrine, Diabetes
Therapuetic Areas:Endocrinology
Age Range:18 - 65
Start Date:November 2014
End Date:December 2019
Contact:Claudia Moore

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Impact of Recurrent Hypoglycemia on Brain Ketone Metabolism in Type 1 Diabetes

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.

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

Inclusion Criteria:

1. Type 1 diabetes mellitus of > 5 years (C-peptide negative, age 18-60 years, on
intensive insulin therapy (HbA1c <7.5%)

2. Non-diabetic volunteers, age 18-65 years that do not meet any of the exclusion

Exclusion Criteria:

1. Pregnancy

2. Significant baseline anemia (hemoglobin <11.0 or hematocrit < 33%)

3. A history of liver cirrhosis or porto-caval shunt surgery.

4. Any contraindications for MRI scanning.

5. Subjects that follow a vegetarian diet

6. Subjects that exercise heavily on a regular basis (i.e. marathon runners, body
builders or other forms of excessive exercise as determined by the PI)

7. Subjects with a history of anxiety/ panic attacks
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