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Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01205347
First Posted: September 20, 2010
Last Update Posted: September 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Andrei C. Sposito, Brasilia Heart Study Group
  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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of the Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Andrei C. Sposito, Brasilia Heart Study Group:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 5 days ]
    Insulin sensitivity as determined by hyperinsulinemic normoglycemic clamp


Secondary Outcome Measures:
  • 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


Enrollment: 27
Study Start Date: October 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01205347


Locations
Brazil
Hospital de Base do Distrito Federal
Brasilia, DF, Brazil, 70000.000
Sponsors and Collaborators
Brasilia Heart Study Group
Investigators
Study Chair: Andrei C Sposito, MD PhD Faculty of Medical Sciences, State University of Campinas
  More Information

Responsible Party: Andrei C. Sposito, Professor of Cardiology, Brasilia Heart Study Group
ClinicalTrials.gov Identifier: NCT01205347     History of Changes
Other Study ID Numbers: Statin_InsulinSensitivity
First Submitted: September 17, 2010
First Posted: September 20, 2010
Last Update Posted: September 10, 2013
Last Verified: September 2013

Keywords provided by Andrei C. Sposito, Brasilia Heart Study Group:
Statin
Myocardial infarction
Insulin sensitivity

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Hypersensitivity
Insulin Resistance
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Simvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors