New Haven, Connecticut 06510


Purpose:

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.


Study summary:

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.


Criteria:

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 criteria. 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


NCT ID:

NCT02471040


Primary Contact:

Principal Investigator
Raimund Herzog, MD
Yale School of Medicine

Claudia Moore
Phone: 2037854707
Email: claudia.moore@yale.edu


Backup Contact:

Email: daniel.spicer@yale.edu
Daniel Spicer
Phone: 2037374773


Location Contact:

New Haven, Connecticut 06510
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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