Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction |
Drug: Simvastatin 80mg Drug: Simvastatin 10mg |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase 4 Study of the Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction |
- Insulin sensitivity [ Time Frame: 5 days ] [ Designated as safety issue: No ]Insulin sensitivity as determined by hyperinsulinemic normoglycemic clamp
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Simvastatin 80mg
Simvastatin 80mg once a day
|
Drug: Simvastatin 80mg
Simvastatin 80mg once a day
Other Name: Zocor
|
|
Active Comparator: Simvastatin 10mg
Simvastatin 10mg once a day
|
Drug: Simvastatin 10mg
Simvastatin 10mg once a day
Other Name: Zocor
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Riobaldo M Cintra, MD | 55 61 3442 8439 | riobaldo99@yahoo.com |
| Contact: Luiz Sergio F Carvalho, MD | 55 61 3442 8439 | luizsergiokk@gmail.com |
| Brazil | |
| Hospital de Base do Distrito Federal | Recruiting |
| Brasilia, DF, Brazil, 70000.000 | |
| Principal Investigator: Luiz Sergio F Carvalho, MD | |
| Study Chair: | Andrei C Sposito, MD PhD | Faculty of Medical Sciences, State University of Campinas |
More Information
No publications provided
| Responsible Party: | Andrei C Sposito, Cardiology Division, Faculty of Medical Sciences, State University of Campinas (Unicamp), |
| ClinicalTrials.gov Identifier: | NCT01205347 History of Changes |
| Other Study ID Numbers: | Statin_InsulinSensitivity |
| Study First Received: | September 17, 2010 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Brasilia Heart Study Group:
|
Statin Myocardial infarction Insulin sensitivity |
Additional relevant MeSH terms:
|
Myocardial Infarction Infarction Insulin Resistance Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
Insulin Simvastatin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013