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

This study is currently recruiting participants.
Verified June 2013 by Yale University
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Robert Sherwin, Yale University
ClinicalTrials.gov Identifier:
NCT01315171
First received: March 11, 2011
Last updated: June 27, 2013
Last verified: June 2013

March 11, 2011
June 27, 2013
January 2012
December 2014   (final data collection date for primary outcome measure)
Cognitive function tests [ Time Frame: 100 minutes ] [ Designated as safety issue: No ]
Cognitive function will be assessed during hypoglycemia. 3 tests will be carried looking at working memory with number and word recollection.
Same as current
Complete list of historical versions of study NCT01315171 on ClinicalTrials.gov Archive Site
Brain activity [ Time Frame: 100 minutes ] [ Designated as safety issue: No ]
The fMRI will be used to assess brain activity during hypoglycemia in the presence of medium chain triglycerides.
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypo-unawareness
  • Type 1 Diabetes.
Dietary Supplement: Medium chain triglycerides
4 tablespoons/day for 2 weeks
  • Experimental: Medium chain supplemented diet
    Subjects will have a diet during which all meals are supplemented with 4 tablespoons of medium chain triglyceride oil.
    Intervention: Dietary Supplement: Medium chain triglycerides
  • No Intervention: Standard group
    Subjects will continue with a standard western diabetes diet.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact: Kimberly Kunze 203-785-7407 kim.kunze@yale.edu
Contact: Renata Belfort De Aguiar, MD 203-785-6222 glucose.studies@yale.edu
United States
 
NCT01315171
HIC1009007394
No
Robert Sherwin, Yale University
Yale University
Juvenile Diabetes Research Foundation
Principal Investigator: Robert Sherwin, MD Yale University
Yale University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP