Effect of a Medium Chain Triglyceride Supplemented Diet on Cognitive Function and Brain Activation in Type 1 Diabetes.
The Effect of a Long-term Medium Chain Supplemented Diet on Cognitive Function and Brain Activation During Hypoglycemia in Type 1 Diabetes.
1 other identifier
interventional
12
1 country
1
Brief Summary
Insulin treatment often causes the blood glucose levels to fall too low (hypoglycemia). Hypoglycemia can be associated with confusion and disorientation as well as other symptoms such as palpitations, sweating and tremors. Medium chain triglycerides (MCT) can be used as a fuel in the brain during low blood sugar levels and therefore may prevent or reduce some of the confusion and disorientation seen during hypoglycemia. We would like to determine if a diet supplemented with medium chain triglycerides can improve cognitive function during hypoglycemia, diabetes control and also look at brain activity.
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 Jan 2012
Longer than P75 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
First Submitted
Initial submission to the registry
March 11, 2011
CompletedFirst Posted
Study publicly available on registry
March 15, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedJanuary 17, 2018
January 1, 2018
3.6 years
March 11, 2011
January 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cognitive function tests
Cognitive function will be assessed during hypoglycemia. 3 tests will be carried looking at working memory with number and word recollection.
100 minutes
Secondary Outcomes (1)
Brain activity
100 minutes
Study Arms (2)
Medium chain supplemented diet
EXPERIMENTALSubjects will have a diet during which all meals are supplemented with 4 tablespoons of medium chain triglyceride oil.
Standard group
NO INTERVENTIONSubjects will continue with a standard western diabetes diet.
Interventions
4 tablespoons/day for 2 weeks
Eligibility Criteria
You may qualify if:
- type 1 diabetes
- HbA1c \<8%
- BMI 18-30
- hypo unawareness
You may not qualify if:
- pregnancy
- significant diabetes complications
- liver disease, cirrhosis
- cardiac disease
- neurological disorder
- kidney disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- Juvenile Diabetes Research Foundationcollaborator
Study Sites (1)
Yale University School of Medicine
New Haven, Connecticut, 06511, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Sherwin, MD
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2011
First Posted
March 15, 2011
Study Start
January 1, 2012
Primary Completion
August 1, 2015
Study Completion
October 1, 2016
Last Updated
January 17, 2018
Record last verified: 2018-01