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临床试验/NCT01315171
NCT01315171已完成不适用

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

Yale University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2012年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Cognitive function tests

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •type 1 diabetes
  • •HbA1c <8%
  • •BMI 18-30
  • •hypo unawareness

排除标准

  • •pregnancy
  • •significant diabetes complications
  • •liver disease, cirrhosis
  • •cardiac disease
  • •neurological disorder
  • •kidney disease

研究组 & 干预措施

Standard group

No Intervention

Subjects will continue with a standard western diabetes diet.

Medium chain supplemented diet

Experimental

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

干预措施: Medium chain triglycerides (Dietary Supplement)

结局指标

主要结局

Cognitive function tests

时间窗: 100 minutes

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

次要结局

  • Brain activity(100 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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