Hypoglycemia Associated Autonomic Dysfunction
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in Plasminogen Activation inhibitor-1 (PAi-1)
研究概览
简要总结
Low blood sugar can negatively affect how blood vessels function, and this can lead to an increase in the risk for heart attacks, strokes and other problems related to the stiffening and blockage of blood vessels. The purpose of this study is to learn if and how glucagon-like peptide-1 (GLP-1; a naturally occurring hormone in the gut) changes the effects that low blood sugar levels have on blood vessels.
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
- Single (Participant)
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
- •14 (7 males, 7 females) healthy controls age 30-60 yr.
- •14 (7 males, 7 females) people with type 2 DM age 30-60 yr.
- •For type 2 DM: HbA1c 6-10.0%
- •No significant diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc.)
- •Body mass index >25kg • m-2
排除标准
- 未提供
研究组 & 干预措施
Glucagon-Like Peptide -1 (GLP-1) infusion
Infusion of GLP-1 during experimental period
干预措施: Glucagon-Like Peptide- 1 (GLP-1) infusion (Drug)
结局指标
主要结局
Change in Plasminogen Activation inhibitor-1 (PAi-1)
时间窗: change from baseline to end of clamp period
measurements of change in PAi-1 at baseline and during the end of the glucose clamp period (2 hours)
Change in Flow mediated dilation (FMD)
时间窗: change from baseline and end of clamp
flow mediated dilation of the brachial artery will be measured for change from baseline and end of glucose clamp (\~4 hours)
次要结局
未报告次要终点
研究者
Stephen N. Davis, MBBS
Chairman of Medicine
University of Maryland, Baltimore