Can Insulin Glargine Improve Myocardial Function in Patients With T2D and Coronary Artery Disease (CAD)
Healthy Heart Study: Can Insulin Glargine Improve Myocardial Function in Patients With Type 2 Diabetes and Coronary Artery Disease? A Prospective, Randomized, Controlled Clinical Study With Blinded Analysis of Ultrasound Data
研究概览
详细说明
This is a single centre, short term (24 weeks), therapy controlled and randomized prospective study with blinded analysis of the ultrasound data in 28 patients with known coronary artery disease, normal systolic cardiac function and with newly diagnosed type 2 diabetes including impaired glucose tolerance who are treated by ≤1 oral antidiabetic medication. After recruitment and informed consent, patients are randomized to two treatment arms which takes into account age and presence or absence of therapy with statins.
In one treatment arm, therapy is based on insulin glargine sc o.d., while in the other treatment arm, therapy is based on oral metformin, up to 2000 mg daily. Both treatment arms will be titrated to the target of fasting glucose ≤110 mg/dl during the first 12 weeks. The patients in the insulin treatment arm will be instructed in the skills of self-medication by the departmental diabetic teaching programme prior to starting study medication and are encouraged to keep records of any episode of hypoglycemia throughout the study.Outpatients visits for metabolic control and ultrasound assessment are at weeks 4, 12 and 24 after baseline and are associated with life style instructions for all patients.
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
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Bavaria
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Munich、Bavaria、德国、81925
- Staedt. Klinikum Muenchen Bogenhausen
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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:
- coronary artery disease
- type 2 diabetes of short duration including impaired glucose tolerance and impaired fasting glucose
- treatment by ≤1 OAD
Exclusion Criteria:
- contraindications for metformin or insulin glargine
- on insulin therapy
- pregnancy and breastfeeding
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:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:insulin glargine
antidiabetic treatment with Lantus o.d.
titrated to the target fasting glucose type 2 diabetes ≤110 mg/dl
|
antidiabetic treatment with insulin glargine sc o.d.
titrated to the target fasting glucose type 2 diabetes ≤110 mg/dl
其他名称:
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有源比较器:metformin
use of oral metformin o.d or b.d titrated up to 2000 mg daily for to the target fasting glucose ≤110 mg/dl
|
use of oral metformin o.d or b.d titrated up to 2000 mg daily for to the target fasting glucose ≤110 mg/dl
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
change from baseline to endpoint in myocardial diastolic velocity E'
大体时间:24 weeks
|
24 weeks
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
glucose control
大体时间:24 weeks
|
24 weeks
|
合作者和调查者
调查人员
- 首席研究员:Helene von Bibra, MD, PhD、Diabetes Centre, Staedt. Klinikum Bogenhausen, Muenchen
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
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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