Phase 4 Study of the Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction
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
Simvastatin 80mg once a day
Intervention: Simvastatin 80mg (Drug)
Simvastatin 10mg
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
Andrei C. Sposito
Professor of Cardiology
Brasilia Heart Study Group
