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临床试验/NCT02747680
NCT02747680已完成不适用

Cerebral Responses to Insulin Induced Hypoglycemia

University of Minnesota2 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2004年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
266
试验地点
2
主要终点
Brain activation during euglycemia (normal blood sugar) using functional MRI

研究概览

简要总结

This research study is designed to investigate the effect of hypoglycemia (low blood sugar) on blood flow to and biochemistry in the brain.

详细描述

The purpose of this study is to better understand the effect of low blood sugar (hypoglycemia) on blood flow and biochemistry in the brain. Hypoglycemia is a serious complication of diabetes treatments. It has been previously observed that hypoglycemia causes an increase in blood flow to certain parts of the brain, but it has been difficult to determine which parts of the brain specifically have an increase in blood flow. With new technology, it is now possible to determine the rate of blood flow in very small parts of the brain. The investigator expects that people with type 1 diabetes and hypoglycemia unawareness, poorly controlled diabetes, and normal subjects will have different rates of blood flow to different parts of the brain in response to hypoglycemia. Having a greater understanding of how the brain adapts to hypoglycemia may help us develop better ways to treat diabetes more safely.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • well controlled type 1 diabetes (hemoglobin A1C <7.5%)
  • healthy controls

排除标准

  • History of stroke, seizures, neurosurgical procedures, or arrhythmias
  • Use of drugs that can alter GABA (gamma-aminobutyric acid) metabolism (such as benzodiazepines).
  • Subjects must also meet requirements for a study in the magnet, which includes weight less than 300 lbs and the absence of metallic substances in their body.

结局指标

主要结局

Brain activation during euglycemia (normal blood sugar) using functional MRI

时间窗: baseline

Brain activation during euglycemia (normal blood sugar) using functional MRI

Brain activation during hypoglycemia (low blood sugar) using functional MRI

时间窗: baseline

Brain activation during hypoglycemia (low blood sugar) using functional MRI

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Cerebral Responses to Insulin Induced Hypoglycemia | 临床试验