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

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ClinicalTrials.gov Identifier: NCT00592072
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : January 5, 2015
Last Update Posted : January 22, 2015
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Yale University

December 26, 2007
January 11, 2008
February 4, 2013
January 5, 2015
January 22, 2015
July 2005
July 2008   (Final data collection date for primary outcome measure)
  • 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.
  • Delayed Verbal Memory [ Time Frame: 90 minutes ]
    The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement.
  • Verbal Memory Recognition [ Time Frame: 90 minutes ]
    The highest score is 15. The lowest score is 0. Higher scores indicate an improvement.
  • Digit Span Backward [ Time Frame: 90 minutes ]
    The highest score is 35. The lowest score is 0. The higher the score indicates an improvement.
  • Letter/Number Sequencing [ Time Frame: 90 minutes ]
    The highest score is 21. The lowest score is 0. Higher scores indicate an improvement.
  • Digit Symbol Coding [ Time Frame: 90 minutes ]
    The highest score is 133. The lowest score is 0. Higher scores indicate an improvement.
  • Map Search (2min) [ Time Frame: 90 minutes ]
    The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
  • Map Search (1min) [ Time Frame: 90 minutes ]
    The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
  • 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.
Cognitive performance [ Time Frame: 90 minutes ]
Complete list of historical versions of study NCT00592072 on ClinicalTrials.gov Archive Site
Not Provided
Blood glucose [ Time Frame: 5 minutes ]
Not Provided
Not Provided
 
Effect of Medium Chain Fatty Acids on Cognitive Function During Acute Hypoglycemia in Patients With Type 1 Diabetes
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.)
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
  • 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
  • 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.
  • Experimental: Medium chain fatty acid (Octanoic and Decanoic acid)
    Intervention: Dietary Supplement: Medium chain fatty acid (Octanoic and Decanoic acid)
  • Placebo Comparator: Splenda (Placebo Control)
    Intervention: Other: Splenda (Placebo Control)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
Same as current
July 2008
July 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00592072
DK66108b_0505000079
R37DK020495 ( U.S. NIH Grant/Contract )
DK20495
No
Not Provided
Not Provided
Yale University
Yale University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Juvenile Diabetes Research Foundation
Principal Investigator: Robert Sherwin, M.D. Yale University
Yale University
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP