Phase 4 Study of the Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Insulin sensitivity
研究概览
简要总结
Stress hyperglycemia during myocardial infarction (MI) is related to mortality at short and long term. Recent studies, however, revealed that chronic statin treatment may decrease both insulin sensitivity and secretion immediately after statin therapy initiation. This study aim was to investigate the dose-dependent effect of statins on insulin sensitivity in patients in the acute phase of MI.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Diabetes or prior use of statins in the last 6 months
研究组 & 干预措施
Simvastatin 80mg
Simvastatin 80mg once a day
干预措施: Simvastatin 80mg (Drug)
Simvastatin 10mg
Simvastatin 10mg once a day
干预措施: Simvastatin 10mg (Drug)
结局指标
主要结局
Insulin sensitivity
时间窗: 5 days
Insulin sensitivity as determined by hyperinsulinemic normoglycemic clamp
次要结局
- Activation of insulin receptor substrate (IRS-1) and Akt protein(5 days)
研究者
Andrei C. Sposito
Professor of Cardiology
Brasilia Heart Study Group
