Clinical trial NCT00592072: Effect of Medium Chain Fatty Acids on Cognitive Function During Acute Hypoglycemia in Patients With Type 1 Diabetes
Official title: Effect of Medium Chain Fatty Acids on Cognitive Function During Acute Hypoglycemia in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes Mellitus, Type 1
Medium Chain Fatty Acid
Hypoglycemia
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Juvenile Diabetes Research Foundation
First posted: 2008-01-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Immediate Verbal Memory
timeFrame: 90 minutes
measure: Delayed Verbal Memory
timeFrame: 90 minutes
measure: Verbal Memory Recognition
timeFrame: 90 minutes
measure: Digit Span Backward
timeFrame: 90 minutes
measure: Letter/Number Sequencing
timeFrame: 90 minutes
measure: Digit Symbol Coding
timeFrame: 90 minutes
measure: Map Search (2min)
timeFrame: 90 minutes
measure: Map Search (1min)
timeFrame: 90 minutes
measure: Telephone Search
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Robert Sherwin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: