Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction
Phase 4 Study of the Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction
研究概览
详细说明
Stress hyperglycemia during myocardial infarction (MI) is a predictor of worse prognosis at short and long term. From the mechanistic standpoint, hyperglycemia can attenuate thrombolysis, increase platelet aggregation, induce coronary vasoconstriction, reduce oxygen transport and prolong endothelial inflammation after MI. Consistently, observational data indicates that glucose normalization improves survival in hyperglycemic patients hospitalized with MI.
High dose potent statins have been included in the early treatment of acute coronary syndromes (ACS) based upon a broad range of potentially beneficial mechanisms. Recent studies, however, revealed that chronic statin treatment may increase the incidence of type 2 diabetes mellitus in a dose-dependent manner. Moreover, according to studies in cellular and animal models, such decrease in insulin sensitivity may be observed immediately after statin therapy initiation. By inference, one may speculate that statin treatment initiated at the acute phase of MI may potentially favor the appearance or aggravation of stress hyperglycemia. To date, however, this hypothesis has not been investigated. Hence, this study aim was to investigate the dose-dependent effect of statins on insulin sensitivity in patients in the acute phase of MI.
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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DF
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Brasilia、DF、巴西、70000.000
- Hospital de Base do Distrito Federal
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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:
- Less than 24 hours after the onset of MI symptoms
- ST-segment elevation of a least 1 mm (frontal plane) or 2 mm (horizontal plane) in two contiguous leads
- Myocardial necrosis, as evidenced by increased Creatine Kinase-MB (CK-MB) and troponin levels
Exclusion Criteria:
- Diabetes or prior use of statins in the last 6 months
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:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Simvastatin 80mg
Simvastatin 80mg once a day
|
Simvastatin 80mg once a day
其他名称:
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有源比较器:Simvastatin 10mg
Simvastatin 10mg once a day
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Simvastatin 10mg once a day
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 |
---|---|---|
Insulin sensitivity
大体时间:5 days
|
Insulin sensitivity as determined by hyperinsulinemic normoglycemic clamp
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5 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Activation of insulin receptor substrate (IRS-1) and Akt protein
大体时间:5 days
|
Verify the degree of phosphorylation of insulin receptor substrate (IRS-1) and Akt protein estimated by Western Blotting of the abdominal adipose tissue obtained by biopsy
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5 days
|
合作者和调查者
调查人员
- 学习椅:Andrei C Sposito, MD PhD、Faculty of Medical Sciences, State University of Campinas
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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