跳至主要内容
临床试验/NCT01205347
NCT01205347已完成4 期

Phase 4 Study of the Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction

Brasilia Heart Study Group1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Simvastatin 80mg once a day

干预措施: Simvastatin 80mg (Drug)

Simvastatin 10mg

Active Comparator

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

发起方
Brasilia Heart Study Group
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrei C. Sposito

Professor of Cardiology

Brasilia Heart Study Group

研究点 (1)

Loading locations...

相似试验