Efficacy of GLP-1 Infusion in Comparison to an Insulin Infusion Protocol to Reach Normoglycemia Type 2 Diabetic Patients
Efficacy of a Continuous GLP-1 Infusion in Comparison to a Structured Insulin Infusion Protocol to Reach Normoglycemia in Non-Fasted Type 2 Diabetic Patients
研究概览
详细说明
Intervention studies in patients with acute myocardial infraction or cardiac surgery, using intravenously administered human insulin, suggest that normalization of hyperglycemia can reduce morbidity as well as mortality in these patients. Insulin-based regimens require frequent blood glucose measurements and adjustments of infusion rate to achieve normoglycemia.
In addition, hypoglycaemia is a frequent and important side effect. Glucagon-Like-Peptide 1 (GLP-1) is an insulinotropic, glucagonostatic gastrointestinal hormone that lowers glucose in a glycemia-dependent manner and therefore does not cause hypoglycemia.
The aim of our study was to compare for the first time efficacy and safety of intravenously administered GLP-1 with an established intravenous insulin regimen in hyperglycaemic type 2 diabetic patients.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Graz、奥地利、8036
- Medical University of Graz, Department for Internal Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Type 2 diabetes mellitus
- Fasting glycemia above 150 mg/dl
- Signed informed consent
Exclusion Criteria:
- Patients with heart failure > NYHA II
- Uncontrolled hypertension
- Impaired kidney function (creatinine > 3 mg/dl)
- Acute infection
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：GLP-1
Intravenously administered GLP-1
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Patients received GLP-1 intravenously at a dose of 1.2 pmol/kg/min for at maximum 8 hours.
其他名称：
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有源比较器：Insulin intravenously
Insulin intravenously according to the Munich registry
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Human regular insulin intravenously according to the Munich-registry.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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time to reach a plasma glucose below 115 mg/dl
大体时间：0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
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0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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plasma glucose after 2 and 4 hours as well as maximum glycemia
大体时间：0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
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0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
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number of hypoglycaemic episodes
大体时间：0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
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0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
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合作者和调查者
调查人员
- 首席研究员：Thomas C Wascher, MD、Medical University of Graz, Dept. of Internal Medicine, Auenbruggerpl. 15, 8036 Graz, Austria
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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