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OpenTrials
Completed

NCT Number: NCT01205347

Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de Base do Distrito Federal

Brasília, Federal District, 70000.000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simvastatin 80mg

Drug

Simvastatin 80mg once a day

Other names: Zocor

Simvastatin 10mg

Drug

Simvastatin 10mg once a day

Other names: Zocor

Primary outcomes

  1. Insulin sensitivity

    Time frame: 5 days

    Insulin sensitivity as determined by hyperinsulinemic normoglycemic clamp

Secondary outcomes

  1. Activation of insulin receptor substrate (IRS-1) and Akt protein

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Brasilia Heart Study Group

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 20, 2010
Registry last updated
Sep 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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