Effect of Medium Chain Fatty Acids on Cognitive Function During Acute Hypoglycemia in Patients With Type 1 Diabetes
3 other identifiers
interventional
12
1 country
1
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.)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2005
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 26, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
January 5, 2015
CompletedJanuary 22, 2015
January 1, 2015
3 years
December 26, 2007
February 4, 2013
January 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Immediate Verbal Memory
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.
90 minutes
Delayed Verbal Memory
The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement.
90 minutes
Verbal Memory Recognition
The highest score is 15. The lowest score is 0. Higher scores indicate an improvement.
90 minutes
Digit Span Backward
The highest score is 35. The lowest score is 0. The higher the score indicates an improvement.
90 minutes
Letter/Number Sequencing
The highest score is 21. The lowest score is 0. Higher scores indicate an improvement.
90 minutes
Digit Symbol Coding
The highest score is 133. The lowest score is 0. Higher scores indicate an improvement.
90 minutes
Map Search (2min)
The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
90 minutes
Map Search (1min)
The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
90 minutes
Telephone Search
This is a ratio of how many symbols are found during a certain period of time. The highest ratio is the best result.
90 minutes
Study Arms (2)
Medium chain fatty acid (Octanoic and Decanoic acid)
EXPERIMENTALSplenda (Placebo Control)
PLACEBO COMPARATORInterventions
Octanoic acid(67%) and Decanoic acid (27%); MCFA 50g total at 25 minute intervals with front loading of 20g then 10g for three administrations.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
No technical limitations were seen.
Results Point of Contact
- Title
- Dr Robert Sherwin
- Organization
- Yale School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Sherwin, M.D.
Yale University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2007
First Posted
January 11, 2008
Study Start
July 1, 2005
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
January 22, 2015
Results First Posted
January 5, 2015
Record last verified: 2015-01