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Completed

NCT Number: NCT00592072

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

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.)

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medium chain fatty acid (Octanoic and Decanoic acid)

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.

Other names: Medium Chain Triglycerides, Octanoic and Decanoic acid, Fractionated coconut oil

Splenda (Placebo Control)

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.

Primary outcomes

  1. Immediate Verbal Memory

    Time frame: 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.

  2. Delayed Verbal Memory

    Time frame: 90 minutes

    The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement.

  3. Verbal Memory Recognition

    Time frame: 90 minutes

    The highest score is 15. The lowest score is 0. Higher scores indicate an improvement.

  4. Digit Span Backward

    Time frame: 90 minutes

    The highest score is 35. The lowest score is 0. The higher the score indicates an improvement.

  5. Letter/Number Sequencing

    Time frame: 90 minutes

    The highest score is 21. The lowest score is 0. Higher scores indicate an improvement.

  6. Digit Symbol Coding

    Time frame: 90 minutes

    The highest score is 133. The lowest score is 0. Higher scores indicate an improvement.

  7. Map Search (2min)

    Time frame: 90 minutes

    The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.

  8. Map Search (1min)

    Time frame: 90 minutes

    The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.

  9. Telephone Search

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Juvenile Diabetes Research Foundation
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jan 11, 2008
Registry last updated
Jan 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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