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

NCT ID: NCT00592072

Last Updated: 2015-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2008-07-31

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Medium chain fatty acid (Octanoic and Decanoic acid)

Group Type: EXPERIMENTAL

Medium chain fatty acid (Octanoic and Decanoic acid)

Intervention Type: DIETARY_SUPPLEMENT

Octanoic acid(67%) and Decanoic acid (27%); MCFA 50g total at 25 minute intervals with front loading of 20g then 10g for three administrations.

Splenda (Placebo Control)

Group Type: PLACEBO_COMPARATOR

Splenda (Placebo Control)

Intervention Type: OTHER

Placebo drink will consist of dietary sweetener Splenda mixed in water at a concentration of 1g/100mL. An unsweetened cherry flavor Koolaid mix will be added at a concentration of 0.3g/100mL of the Splenda drink to enhance flavor.

Interventions

Medium chain fatty acid (Octanoic and Decanoic acid)

Octanoic acid(67%) and Decanoic acid (27%); MCFA 50g total at 25 minute intervals with front loading of 20g then 10g for three administrations.

Intervention Type: DIETARY_SUPPLEMENT

Splenda (Placebo Control)

Placebo drink will consist of dietary sweetener Splenda mixed in water at a concentration of 1g/100mL. An unsweetened cherry flavor Koolaid mix will be added at a concentration of 0.3g/100mL of the Splenda drink to enhance flavor.

Intervention Type: OTHER

Other Intervention Names

Medium Chain Triglycerides; Octanoic and Decanoic acid; Fractionated coconut oil

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Sherwin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

R37DK020495

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK20495

Identifier Type: -

Identifier Source: secondary_id

DK66108b_0505000079

Identifier Type: -

Identifier Source: org_study_id