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

This study has been completed.
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00592072
First received: December 26, 2007
Last updated: January 8, 2015
Last verified: January 2015
  Purpose

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.)


Condition Intervention
Diabetes Mellitus, Type 1
Dietary Supplement: Medium chain fatty acid (Octanoic and Decanoic acid)
Other: Splenda (Placebo Control)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Medium Chain Fatty Acids on Cognitive Function During Acute Hypoglycemia in Patients With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Immediate Verbal Memory [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    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.

  • Delayed Verbal Memory [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement.

  • Verbal Memory Recognition [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    The highest score is 15. The lowest score is 0. Higher scores indicate an improvement.

  • Digit Span Backward [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    The highest score is 35. The lowest score is 0. The higher the score indicates an improvement.

  • Letter/Number Sequencing [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    The highest score is 21. The lowest score is 0. Higher scores indicate an improvement.

  • Digit Symbol Coding [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    The highest score is 133. The lowest score is 0. Higher scores indicate an improvement.

  • Map Search (2min) [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.

  • Map Search (1min) [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.

  • Telephone Search [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    This is a ratio of how many symbols are found during a certain period of time. The highest ratio is the best result.


Enrollment: 12
Study Start Date: July 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medium chain fatty acid (Octanoic and Decanoic acid) Dietary Supplement: 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.
Other Names:
  • Medium Chain Triglycerides
  • Octanoic and Decanoic acid
  • Fractionated coconut oil
Placebo Comparator: Splenda (Placebo Control) Other: 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.

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592072

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Juvenile Diabetes Research Foundation
Investigators
Principal Investigator: Robert Sherwin, M.D. Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00592072     History of Changes
Other Study ID Numbers: DK66108b_0505000079, R37DK020495, DK20495
Study First Received: December 26, 2007
Results First Received: February 4, 2013
Last Updated: January 8, 2015
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Diabetes Mellitus, Type 1
Medium Chain Fatty Acid
Hypoglycemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Decanoic acid
Anti-Infective Agents
Antifungal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2015