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

Hypo-unawareness research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hypo-unawareness

Type 1 Diabetes Mellitus

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Dietary Supplement:Medium chain triglycerides4 tablespoons/day for 2 weeks

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Medium chain supplemented dietSubjects will have a diet during which all meals are supplemented with 4 tablespoons of medium chain triglyceride oil.

Standard groupSubjects will continue with a standard western diabetes diet.

Study Status

Completed

Start Date: January 2012

Completed Date: October 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Cognitive function tests

Secondary Outcome: Brain activity

Study sponsors, principal investigator, and references

Principal Investigator: Robert Sherwin, MD

Lead Sponsor: Yale University

Collaborator: Juvenile Diabetes Research Foundation

More information:https://clinicaltrials.gov/show/NCT01315171

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