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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 January 2012 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: January 25, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Hypo-unawareness
Type 1 Diabetes.
 Dietary Supplement: Medium chain triglycerides

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of a Long-term Medium Chain Supplemented Diet on Cognitive Function and Brain Activation During Hypoglycemia in Type 1 Diabetes.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medium chain supplemented diet
Subjects will have a diet during which all meals are supplemented with 4 tablespoons of medium chain triglyceride oil.
 Dietary Supplement: Medium chain triglycerides
4 tablespoons/day for 2 weeks
No Intervention: Standard group
Subjects will continue with a standard western diabetes diet.
 Dietary Supplement: Medium chain triglycerides
4 tablespoons/day for 2 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315171

Contacts
Contact: Sarita Naik, MD 203-785-6222 sarita.naik@yale.edu

Locations
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06511
Contact: Sarita Naik, MD     203-785-6222     sarita.naik@yale.edu    
Contact: Robert Sherwin, MD     203-785-4183     robert.sherwin@yale.edu    
Sub-Investigator: Sarita naik, MD            
Sponsors and Collaborators
Yale University
Juvenile Diabetes Research Foundation
Investigators
Principal Investigator: Robert Sherwin, MD Yale University
  More Information

No publications provided

Responsible Party: Robert Sherwin, Chief of Endocrinology, Yale University
ClinicalTrials.gov Identifier: NCT01315171     History of Changes
Other Study ID Numbers: HIC1009007394
Study First Received: March 11, 2011
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
medium chain triglycerides
hypoglycemia
cognitive function
functional MRI

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Unconsciousness
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013