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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01315171
• Other study ID #: 1009007394
• Status: Completed
• Phase: N/A
• First received: March 11, 2011
• Last updated: January 12, 2018
• Start date: January 2012
• Est. completion date: October 2016

Study information

• Verified date: January 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypo-unawareness
• Type 1 Diabetes Mellitus
• Unconsciousness

Intervention

Dietary Supplement:
• Medium chain triglycerides
4 tablespoons/day for 2 weeks

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Brain activity	The fMRI will be used to assess brain activity during hypoglycemia in the presence of medium chain triglycerides.	100 minutes