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.

Sponsors

Lead Sponsor: Yale University

Collaborator: Juvenile Diabetes Research Foundation

Source Yale University
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.

Overall Status Completed
Start Date January 2012
Completion Date October 2016
Primary Completion Date August 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Cognitive function tests 100 minutes
Secondary Outcome
Measure Time Frame
Brain activity 100 minutes
Enrollment 12
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Medium chain triglycerides

Description: 4 tablespoons/day for 2 weeks

Arm Group Label: Medium chain supplemented diet

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Robert Sherwin, MD Principal Investigator Yale University
Location
Facility: Yale University School of Medicine
Location Countries

United States

Verification Date

January 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Medium chain supplemented diet

Type: Experimental

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

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov