Effect of a Medium Chain Triglyceride Supplemented Diet on Cognitive Function and Brain Activation in Type 1 Diabetes.

Not Applicable

Completed

• Conditions: Hypo-unawareness; Type 1 Diabetes Mellitus
• Interventions: Dietary Supplement: Medium chain triglycerides

• Registration Number: NCT01315171
• Lead Sponsor: 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-03-11
• Study First Submitted QC: 2011-03-11
• Study First Posted: 2011-03-15
• Study Start: 2012-01
• Primary Completion: 2015-08
• Study Completion: 2016-10
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-12
• Last Update Posted: 2018-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• type 1 diabetes
• HbA1c <8%
• BMI 18-30
• hypo unawareness

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Exclusion Criteria

• pregnancy
• significant diabetes complications
• liver disease, cirrhosis
• cardiac disease
• neurological disorder
• kidney disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medium chain supplemented diet	Medium chain triglycerides	Subjects will have a diet during which all meals are supplemented with 4 tablespoons of medium chain triglyceride oil.

Primary Outcome Measures

Name	Time	Method
Cognitive function tests	100 minutes	Cognitive function will be assessed during hypoglycemia. 3 tests will be carried looking at working memory with number and word recollection.

Secondary Outcome Measures

Name	Time	Method
Brain activity	100 minutes	The fMRI will be used to assess brain activity during hypoglycemia in the presence of medium chain triglycerides.

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States