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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of a Long-term Medium Chain Supplemented Diet on Cognitive Function and Brain Activation During Hypoglycemia in Type 1 Diabetes.

Conditions
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Hypo-unawareness, Type 1 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Medium chain triglycerides


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medium chain supplemented diet<br>Subjects will have a diet during which all meals are supplemented with 4 tablespoons of medium chain triglyceride oil. | Dietary Supplement: Medium chain triglycerides<br>* 4 tablespoons/day for 2 weeks<br>|
| No Intervention: Standard group<br>Subjects will continue with a standard western diabetes diet. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain activity | The fMRI will be used to assess brain activity during hypoglycemia in the presence of medium chain triglycerides. | 100 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medium chain triglycerides, hypoglycemia, cognitive function, functional MRI