Effect of a Medium Chain Triglyceride Supplemented Diet on Cognitive Function and Brain Activation in Type 1 Diabetes.
Primary Purpose
Hypo-unawareness, Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medium chain triglycerides
Sponsored by
About this trial
This is an interventional treatment trial for Hypo-unawareness focused on measuring medium chain triglycerides, hypoglycemia, cognitive function, functional MRI
Eligibility Criteria
Inclusion Criteria:
- type 1 diabetes
- HbA1c <8%
- BMI 18-30
- hypo unawareness
Exclusion Criteria:
- pregnancy
- significant diabetes complications
- liver disease, cirrhosis
- cardiac disease
- neurological disorder
- kidney disease
Sites / Locations
- Yale University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Medium chain supplemented diet
Standard group
Arm Description
Subjects will have a diet during which all meals are supplemented with 4 tablespoons of medium chain triglyceride oil.
Subjects will continue with a standard western diabetes diet.
Outcomes
Primary Outcome Measures
Cognitive function tests
Cognitive function will be assessed during hypoglycemia. 3 tests will be carried looking at working memory with number and word recollection.
Secondary Outcome Measures
Brain activity
The fMRI will be used to assess brain activity during hypoglycemia in the presence of medium chain triglycerides.
Full Information
NCT ID
NCT01315171
First Posted
March 11, 2011
Last Updated
January 12, 2018
Sponsor
Yale University
Collaborators
Juvenile Diabetes Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01315171
Brief Title
Effect of a Medium Chain Triglyceride Supplemented Diet on Cognitive Function and Brain Activation in Type 1 Diabetes.
Official Title
The Effect of a Long-term Medium Chain Supplemented Diet on Cognitive Function and Brain Activation During Hypoglycemia in Type 1 Diabetes.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Juvenile Diabetes Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
30 subjects with well controlled type 1 diabetes will be recruited for the study. If you agree to participate you will be scheduled for, dietitian visits, and a study visit which will include insulin and glucose infusions, an MRI scan and brain function tests. All visits will be on the Hospital Research Unit (HRU) on the 10th floor of Yale New Haven Hospital. You will be randomized to either the MCT-supplemented diet or the standardized western diabetic diet. If you are on the MCT diet, the MCT oil will be given to you and you will be shown how to incorporate it into your diet. The MCT supplemented diet is for two weeks (with a two gradual transition onto the diet) and the standardized western diet is for two weeks (with a 1 week transition onto the diet). At the end of the study you will be admitted to the Hospital Research Unit for the insulin 'clamp' and MRI scan. A 'clamp' is a procedure which involves insulin and glucose infusions. During a 'clamp' study, the insulin infusion is held constant, while the glucose infusion is adjusted every 5 minutes as needed to maintain the desired blood glucose levels. Compensation for the study is $750.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypo-unawareness, Type 1 Diabetes Mellitus
Keywords
medium chain triglycerides, hypoglycemia, cognitive function, functional MRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medium chain supplemented diet
Arm Type
Experimental
Arm Description
Subjects will have a diet during which all meals are supplemented with 4 tablespoons of medium chain triglyceride oil.
Arm Title
Standard group
Arm Type
No Intervention
Arm Description
Subjects will continue with a standard western diabetes diet.
Intervention Type
Dietary Supplement
Intervention Name(s)
Medium chain triglycerides
Intervention Description
4 tablespoons/day for 2 weeks
Primary Outcome Measure Information:
Title
Cognitive function tests
Description
Cognitive function will be assessed during hypoglycemia. 3 tests will be carried looking at working memory with number and word recollection.
Time Frame
100 minutes
Secondary Outcome Measure Information:
Title
Brain activity
Description
The fMRI will be used to assess brain activity during hypoglycemia in the presence of medium chain triglycerides.
Time Frame
100 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
type 1 diabetes
HbA1c <8%
BMI 18-30
hypo unawareness
Exclusion Criteria:
pregnancy
significant diabetes complications
liver disease, cirrhosis
cardiac disease
neurological disorder
kidney disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Sherwin, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of a Medium Chain Triglyceride Supplemented Diet on Cognitive Function and Brain Activation in Type 1 Diabetes.
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