MedDataX Logo

Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction

NCT ID: NCT01205347

Last Updated: 2013-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myocardial Infarction

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Statin Myocardial infarction Insulin sensitivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Simvastatin 80mg

Simvastatin 80mg once a day

Group Type EXPERIMENTAL

Simvastatin 80mg

Intervention Type DRUG

Simvastatin 80mg once a day

Simvastatin 10mg

Simvastatin 10mg once a day

Group Type ACTIVE_COMPARATOR

Simvastatin 10mg

Intervention Type DRUG

Simvastatin 10mg once a day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Simvastatin 80mg

Simvastatin 80mg once a day

Intervention Type DRUG

Simvastatin 10mg

Simvastatin 10mg once a day

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zocor Zocor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Brasilia Heart Study Group

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Andrei C. Sposito

Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrei C Sposito, MD PhD

Role: STUDY_CHAIR

Faculty of Medical Sciences, State University of Campinas

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital de Base do Distrito Federal

Brasília, Federal District, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Statin_InsulinSensitivity

Identifier Type: -

Identifier Source: org_study_id