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

Yale University

Status: Completed

Conditions: Diabetes Mellitus, Type 1

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00592072

R37DK020495 (U.S. NIH Grant/Contract)

DK20495

DK66108b_0505000079

Details and patient eligibility

About

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.)

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

Medium chain fatty acid (Octanoic and Decanoic acid)

Experimental group

Treatment:

Dietary Supplement: Medium chain fatty acid (Octanoic and Decanoic acid)

Splenda (Placebo Control)

Placebo Comparator group

Treatment:

Other: Splenda (Placebo Control)