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.
Lead Sponsor: Yale University
Collaborator: Juvenile Diabetes Research Foundation
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.
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.
|Start Date||January 2012|
|Completion Date||October 2016|
|Primary Completion Date||August 2015|
Intervention Type: Dietary Supplement
Intervention Name: Medium chain triglycerides
Description: 4 tablespoons/day for 2 weeks
Arm Group Label: Medium chain supplemented diet
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
- type 1 diabetes
- HbA1c <8%
- BMI 18-30
- hypo unawareness
- significant diabetes complications
- liver disease, cirrhosis
- cardiac disease
- neurological disorder
- kidney disease
Minimum Age: 18 Years
Maximum Age: 55 Years
Healthy Volunteers: No
|Has Expanded Access||No|
|Number Of Arms||2|
Label: Medium chain supplemented diet
Description: Subjects will have a diet during which all meals are supplemented with 4 tablespoons of medium chain triglyceride oil.
Label: Standard group
Type: No Intervention
Description: Subjects will continue with a standard western diabetes diet.
|Study Design Info||
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)