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OpenTrials
Completed

NCT Number: NCT01315171

Effect of a Medium Chain Triglyceride Supplemented Diet on Cognitive Function and Brain Activation 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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medium chain triglycerides

Dietary Supplement

4 tablespoons/day for 2 weeks

Primary outcomes

  1. Cognitive function tests

    Time frame: 100 minutes

    Cognitive function will be assessed during hypoglycemia. 3 tests will be carried looking at working memory with number and word recollection.

Secondary outcomes

  1. Brain activity

    Time frame: 100 minutes

    The fMRI will be used to assess brain activity during hypoglycemia in the presence of medium chain triglycerides.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Juvenile Diabetes Research Foundation

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Mar 15, 2011
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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