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
  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

Resource links provided by NLM:


Further study details as provided by Brasilia Heart Study Group:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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 ] [ 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


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

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 17, 2010
Last Updated: September 8, 2013
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:
Infarction
Myocardial 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 July 28, 2014