Skip to main content
Clinical Trials/NCT01205347
NCT01205347CompletedPhase 4

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

Brasilia Heart Study Group1 site in 1 country27 target enrollmentStarted: October 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
27
Locations
1
Primary Endpoint
Insulin sensitivity

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Simvastatin 80mg

Experimental

Simvastatin 80mg once a day

Intervention: Simvastatin 80mg (Drug)

Simvastatin 10mg

Active Comparator

Simvastatin 10mg once a day

Intervention: Simvastatin 10mg (Drug)

Outcomes

Primary Outcomes

Insulin sensitivity

Time Frame: 5 days

Insulin sensitivity as determined by hyperinsulinemic normoglycemic clamp

Secondary Outcomes

  • Activation of insulin receptor substrate (IRS-1) and Akt protein(5 days)

Investigators

Sponsor
Brasilia Heart Study Group
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Andrei C. Sposito

Professor of Cardiology

Brasilia Heart Study Group

Study Sites (1)

Loading locations...

Similar Trials