The Effects of Antecedent Hypoglycemia or Exercise on the Response of the Brain to Subsequent Hypoglycemia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- fMRi scans
研究概览
简要总结
The studies proposed in this application seek to use non-invasive techniques to examine the impact of repeated hypoglycemia on the brain.
详细描述
The studies proposed in this application seek to use non-invasive techniques to examine the impact of repeated hypoglycemia on the brain.
During the past decade many studies have shown that appropriate magnetic resonance imaging (MRI) methods may be used to assess alterations in brain regional activation in response to external stimuli or tasks. Thus, this non-invasive technique will enhance our ability to learn more about brain function, during hypoglycemia and may delineate information about the role of the brain in hypoglycemia associated autonomic dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects aged 18-45
- •Type 1 diabetes mellitus patients aged 18-45
- •Body Mass Index 21-38 kg/m2
- •Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities and an EKG stress test.
- •Female volunteers of childbearing potential will undergo HCG pregnancy test. Only women who are not pregnant will participate in the study.
- •Diabetic Subjects:
- •HBA1C= 5.5-11.0%
- •Duration of Type 1 Diabetes > 3 yr
- •Normal bedside autonomic function
排除标准
- •All Subjects
- •Prior or current history of poor health
- •Abnormal results following screening tests
- •Pregnancy
- •Subjects unable to give voluntary informed consent
- •Subjects with a recent medical illness
- •Subjects with a history of hypertension, heart disease or cerebrovascular disease
- •Subjects with known liver or kidney disease
- •Subjects with recent weight loss or consuming a low carbohydrate diet
- •Subjects taking steroids
- •Subjects taking beta-blockers
- •Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
- •Evidence of diabetic neuropathy, autonomic neuropathy, proteinuria, extensive background or proliferative retinopathy, hypertension, or cardiovascular disease
结局指标
主要结局
fMRi scans
时间窗: 1 day
次要结局
未报告次要终点
研究者
Steve Davis
Chairman of Medicine
Vanderbilt University