Effect of Medium Chain Fatty Acids on Cognitive Function During Acute Hypoglycemia in Patients With Type 1 Diabetes
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
- Delayed Verbal Memory
研究概览
简要总结
At present, there are no therapeutic agents that can minimize severe hypoglycemia (low blood sugar) and its effects on long-term brain function. The aim of this study is to determine whether the human brain is able to use medium chain fatty acids (MCFA) and/or their metabolites as an alternative fuel source during acute hypoglycemia in patients with Type 1 Diabetes Mellitus (T1DM). The hypothesis is that medium chain fatty acids will provide a rapidly absorbed, non-carbohydrate fuel that will improve cognitive performance during episodes of hypoglycemia (low blood sugar.)
详细描述
Twelve subjects between the ages of 18 years and 55 years who have had Type 1 Diabetes Mellitus for more than five years and have had tight control of their diabetes as determined by screening blood work will be invited to participate. Each study subject will undergo two hypoglycemic clamp studies (a procedure where the blood sugar is closely regulated with intravenous insulin and glucose.) In these hypoglycemic clamp studies, cognitive testing will be performed during 90 minutes of normal blood glucose followed by 90 minutes of hypoglycemia. During the hypoglycemic period, either the MCFA or a placebo will be administered. Each subject will experience both conditions. The order in which the MCFA is given will be randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 Mellitus for greater than 5 years (C-peptide negative)
- •Age 18-55 years
- •Subject is on intensive insulin therapy resulting in a Hemoglobin A1c of less than 7.5%
- •History of frequent hypoglycemic events as defined as having at least one blood glucose of less than 60 mg/dl in the last four weeks
排除标准
- •History of hypoglycemia induced seizures
- •Pregnancy
- •Significant baseline anemia (hemoglobin < 11.0g/dl or hematocrit < 33%)
- •A history of liver cirrhosis or porto-caval shunt surgery
研究组 & 干预措施
Medium chain fatty acid (Octanoic and Decanoic acid)
干预措施: Medium chain fatty acid (Octanoic and Decanoic acid) (Dietary Supplement)
Splenda (Placebo Control)
干预措施: Splenda (Placebo Control) (Other)
结局指标
主要结局
Delayed Verbal Memory
时间窗: 90 minutes
The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement.
Verbal Memory Recognition
时间窗: 90 minutes
The highest score is 15. The lowest score is 0. Higher scores indicate an improvement.
Letter/Number Sequencing
时间窗: 90 minutes
The highest score is 21. The lowest score is 0. Higher scores indicate an improvement.
Digit Symbol Coding
时间窗: 90 minutes
The highest score is 133. The lowest score is 0. Higher scores indicate an improvement.
Map Search (1min)
时间窗: 90 minutes
The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
Map Search (2min)
时间窗: 90 minutes
The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
Telephone Search
时间窗: 90 minutes
This is a ratio of how many symbols are found during a certain period of time. The highest ratio is the best result.
Immediate Verbal Memory
时间窗: 90 minutes
Results of cognitive function in diabetic patients using tests such as digit symbol substitution (a test of memory), tests of everyday attention, telephone book searching and map searching during either administration of medium chain triglyceride oil or a control solution. The goal was to determine whether the human brain is able to use medium-chain fatty acids (MCFA) and /or their metabolites as an alternative fuel source and thus improve brain function during acute hypoglycemia in patients with type 1 diabetes. The lowest score is 0 and the highest score is 25. A higher score is an improvement.
Digit Span Backward
时间窗: 90 minutes
The highest score is 35. The lowest score is 0. The higher the score indicates an improvement.
次要结局
未报告次要终点