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Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrei C. Sposito, Brasilia Heart Study Group
ClinicalTrials.gov Identifier:
NCT01205347
First received: September 17, 2010
Last updated: September 8, 2013
Last verified: September 2013

September 17, 2010
September 8, 2013
October 2010
September 2013   (final data collection date for primary outcome measure)
Insulin sensitivity [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Insulin sensitivity as determined by hyperinsulinemic normoglycemic clamp
Same as current
Complete list of historical versions of study NCT01205347 on ClinicalTrials.gov Archive Site
Activation of insulin receptor substrate (IRS-1) and Akt protein [ Time Frame: 5 days ] [ Designated as safety issue: No ]
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
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Infarction
  • Drug: Simvastatin 80mg
    Simvastatin 80mg once a day
    Other Name: Zocor
  • Drug: Simvastatin 10mg
    Simvastatin 10mg once a day
    Other Name: Zocor
  • Experimental: Simvastatin 80mg
    Simvastatin 80mg once a day
    Intervention: Drug: Simvastatin 80mg
  • Active Comparator: Simvastatin 10mg
    Simvastatin 10mg once a day
    Intervention: Drug: Simvastatin 10mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
40 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01205347
Statin_InsulinSensitivity
No
Andrei C. Sposito, Brasilia Heart Study Group
Brasilia Heart Study Group
Not Provided
Study Chair: Andrei C Sposito, MD PhD Faculty of Medical Sciences, State University of Campinas
Brasilia Heart Study Group
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP