Effect of Medium Chain Fatty Acids on Cognitive Function During Acute Hypoglycemia in Patients With Type 1 Diabetes

Not Applicable

Completed

Conditions: Diabetes Mellitus, Type 1

Interventions: Dietary Supplement: Medium chain fatty acid (Octanoic and Decanoic acid)
Other: Splenda (Placebo Control)

Registration Number: NCT00592072

Lead Sponsor: Yale University

Brief Summary: At present, there are no therapeutic agents that can minimize severe hypoglycemia (low blood sugar) and its effects on long-term brain function. The aim of this study is to determine whether the human brain is able to use medium chain fatty acids (MCFA) and/or their metabolites as an alternative fuel source during acute hypoglycemia in patients with Type 1 Diabetes Mellitus (T1DM). The hypothesis is that medium chain fatty acids will provide a rapidly absorbed, non-carbohydrate fuel that will improve cognitive performance during episodes of hypoglycemia (low blood sugar.)

Detailed Description: Twelve subjects between the ages of 18 years and 55 years who have had Type 1 Diabetes Mellitus for more than five years and have had tight control of their diabetes as determined by screening blood work will be invited to participate. Each study subject will undergo two hypoglycemic clamp studies (a procedure where the blood sugar is closely regulated with intravenous insulin and glucose.) In these hypoglycemic clamp studies, cognitive testing will be performed during 90 minutes of normal blood glucose followed by 90 minutes of hypoglycemia. During the hypoglycemic period, either the MCFA or a placebo will be administered. Each subject will experience both conditions. The order in which the MCFA is given will be randomized.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 12

Inclusion Criteria

Type 1 Diabetes Mellitus for greater than 5 years (C-peptide negative)
Age 18-55 years
Subject is on intensive insulin therapy resulting in a Hemoglobin A1c of less than 7.5%
History of frequent hypoglycemic events as defined as having at least one blood glucose of less than 60 mg/dl in the last four weeks

Exclusion Criteria

History of hypoglycemia induced seizures
Pregnancy
Significant baseline anemia (hemoglobin < 11.0g/dl or hematocrit < 33%)
A history of liver cirrhosis or porto-caval shunt surgery

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Medium chain fatty acid (Octanoic and Decanoic acid)	Medium chain fatty acid (Octanoic and Decanoic acid)	-
Splenda (Placebo Control)	Splenda (Placebo Control)	-

Primary Outcome Measures

Name	Time	Method
Delayed Verbal Memory	90 minutes	The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement.
Verbal Memory Recognition	90 minutes	The highest score is 15. The lowest score is 0. Higher scores indicate an improvement.
Letter/Number Sequencing	90 minutes	The highest score is 21. The lowest score is 0. Higher scores indicate an improvement.
Digit Symbol Coding	90 minutes	The highest score is 133. The lowest score is 0. Higher scores indicate an improvement.
Map Search (1min)	90 minutes	The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
Map Search (2min)	90 minutes	The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
Telephone Search	90 minutes	This is a ratio of how many symbols are found during a certain period of time. The highest ratio is the best result.
Immediate Verbal Memory	90 minutes	Results of cognitive function in diabetic patients using tests such as digit symbol substitution (a test of memory), tests of everyday attention, telephone book searching and map searching during either administration of medium chain triglyceride oil or a control solution. The goal was to determine whether the human brain is able to use medium-chain fatty acids (MCFA) and /or their metabolites as an alternative fuel source and thus improve brain function during acute hypoglycemia in patients with type 1 diabetes. The lowest score is 0 and the highest score is 25. A higher score is an improvement.
Digit Span Backward	90 minutes	The highest score is 35. The lowest score is 0. The higher the score indicates an improvement.