Effect of Dapagliflozine on Systemic and Renal Endothelial Function
Effect of Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor on Systemic and Renal Endothelial Function in Patients With Type 2 Diabetes Mellitus Without History of Coronary Artery Disease (SOCCER Trial)
This is a phase 4, single center, randomized, open-labeled, cross-over design study. The primary objective of the study is to compare effect of dapagliflozine and metformin on endothelial function.
Subjects are randomized to initial metformin or initial dapagliflozin group and maintained initial treatment for 8 weeks. During that period, dose of dapagliflozin is maintained 10mg/day and metformin can be titrated upto 2000 mg/day. After 1 weeks of washout period, 8 weeks' cross-over is followed.
研究概览
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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Seoul、大韩民国、156-707
- 招聘中
- Boramae Medical Center
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首席研究员：
- Min Kyong Moon
-
接触：
- Bokyung Koo
- 邮箱：bokyungkoomd@gmail.com
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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:
- Present with type 2 diabetes based on the disease diagnostic criteria as described by the World Health Organization (WHO)
- Treated with diet and exercise alone for recent 3 months
- Aged 20-80 years
- HbA1c 7~9%
This inclusion criterion applies to females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause) only.
- Are not breastfeeding.
- Test negative for pregnancy at the time of screening based on a blood serum pregnancy test.
- Intend not to become pregnant during the study.
Exclusion Criteria:
- Previous history of IHD or brain infarct
- Having typical anginal pain or atypical chest pain with dyspnea
- Modification of Diet in Renal Disease (MDRD) estimated GFR≥60 mL/min
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 |
|---|---|
|
有源比较器：Metformin first
Metformin first 8 wks --> Dapagliflozin 8wks. Metformin for initial 8 weeks. During that period, metformin can be titrated upto 2000 mg/day. After 1 weeks of washout period, 8 weeks' dapagliflozin is followed. During that period, dose of dapagliflozin is maintained 10mg/day. |
其他名称：
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有源比较器：Dapagliflozin first
Dapagliflozin first 8 wks --> Metformin 8wks. Dapagliflozin for initial 8 weeks. After 1 weeks of washout period, 8 weeks' metformin is followed. |
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 |
措施说明 |
大体时间 |
|---|---|---|
|
Reactive hyperemic index to measure endothelial function
大体时间：8 weeks
|
endothelial function
|
8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
N-acetyl-β-D-glucosaminidase as a measure of renal tubular injury
大体时间：8 week
|
renal tubular injury
|
8 week
|
|
Urine albumin excretion ratio
大体时间：8 week
|
Urine albumin excretion
|
8 week
|
|
Urine β2 microglobulin
大体时间：8 week
|
8 week
|
合作者和调查者
调查人员
- 首席研究员：Min Kyong Moon, MD PhD、Boramae medical center, 20 Boramae-ro 5-gil,Dongjak-Gu,Seoul 156-707, Korea
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
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.