Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake
2019年8月5日 更新者：Kieren Mather、Indiana University
27 Type 2 diabetic subjects (HbA1c 7.5 - 9.5%) currently treated with diet and exercise alone or with oral antidiabetic agents will be randomly assigned to one of three treatment groups: insulin detemir, liraglutide, or liraglutide plus detemir (9 subjects per group), on a background of metformin 2000 mg per day.
After 3 months' treatment, PET measurements of myocardial fuel selection will take place, under fasting conditions in the morning following that day's treatment injection(s).
研究概览
详细说明
The investigators will test the hypothesis that effects of liraglutide plus insulin detemir on myocardial fuel selection will be greater than the effects of either agent alone.
27 Type 2 diabetic subjects (HbA1c 7.5 - 9.5%) currently treated with diet and exercise alone or with oral antidiabetic agents will be randomly assigned to one of three treatment groups: insulin detemir, liraglutide, or liraglutide plus detemir (9 subjects per group).
All subjects will undergo an initial standardization of background treatment to metformin 2000 mg per day, followed by randomized assignment to 3 months' treatment with liraglutide 1.8 mg/day (once daily each morning, tapering up according to label instructions) and/or detemir (administered twice daily, initially at 10 units per day then titrated to achieve fasting morning glucose readings below 130 mg/dL).
PET measurements of myocardial fuel selection will take place at the end of this treatment period, under fasting conditions in the morning following that day's treatment injection(s).
研究类型
介入性
注册 (实际的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Indiana
-
Indianapolis、Indiana、美国、46202
- Indiana Clinical Research Center
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 50年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Type 2 diabetic
- 18-50 years
- BMI > 25kg/m2
- HbA1c 7.0-10.0%
- Treated with up to 2 oral agents
Exclusion Criteria:
- Chronic illness or infection (other than diabetes mellitus)
- Known coronary artery disease, structural heart disease or abnormal ECG on screen.
- Treatment with >2 antihypertensive agents or blood pressure >140/95 on two occasions during screening
- History of claustrophobia, musculoskeletal or other factors which would result in an inability to comfortably remain within the PET scanner gantry for the duration of the imaging protocol.
- Occupational, investigational or other known radiation exposure which together with the planned radiologic studies, will result in greater than 500 mrem total exposure in a 12 month period.
- Current pregnancy
- Treatment with GLP-1 agonist or DPP4 inhibitor within the past 6 months
- Known intolerance to GLP-1 agonist
- Personal history of pancreatitis, personal or family history of medullary thyroid carcinoma, or other contraindications to liraglutide treatment.
- Recognized microvascular complications (neuropathy, nephropathy, retinopathy).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Iiraglutide
Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day.
PET measurements of myocardial glucose uptake will take place at the end of treatment.
|
1.8mg subcutaneous qd for 3 months
其他名称：
|
|
实验性的：insulin detemir
Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day.
PET measurements of myocardial glucose uptake will take place at the end of treatment.
|
5units subcutaneous bid titrated to fasting glucose of <130mg/dL for 3 months
其他名称：
|
|
实验性的：Liraglutide plus insulin detemir
Type 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day.
PET measurements of myocardial glucose uptake will take place at the end of treatment.
|
liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose <130mg/dL for 3 months.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Myocardial Glucose Uptake
大体时间：3 months
|
PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir
|
3 months
|
|
Myocardial Fatty Acid Oxidation Rate
大体时间：3 months
|
PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir
|
3 months
|
|
Myocardial Fatty Acid Esterification Rate
大体时间：3 months
|
PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir
|
3 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年1月1日
初级完成 (实际的)
2017年9月8日
研究完成 (实际的)
2017年9月8日
研究注册日期
首次提交
2010年11月1日
首先提交符合 QC 标准的
2010年11月1日
首次发布 (估计)
2010年11月2日
研究记录更新
最后更新发布 (实际的)
2019年8月7日
上次提交的符合 QC 标准的更新
2019年8月5日
最后验证
2019年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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