Hypo-unawareness, Type 1 Diabetes Mellitus
Conditions
Keywords
medium chain triglycerides, hypoglycemia, cognitive function, functional MRI
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.
Interventions
DIETARY_SUPPLEMENTMedium chain triglycerides
4 tablespoons/day for 2 weeks
Sponsors
Juvenile Diabetes Research Foundation
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Brain activity | 100 minutes | The fMRI will be used to assess brain activity during hypoglycemia in the presence of medium chain triglycerides. |
Countries
United States
Outcome results
None listed