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Intravenous Insulin in Patients With Diabetes After Percutaneous Coronary Intervention (PCI)

NCT ID: NCT00967642

Last Updated: 2009-08-28

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

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-04-30

Brief Summary

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The purpose of this study is to evaluate the effects of intravenous insulin/24 hours to normalize glycemia upon markers of oxidative stress (protein oxidation and total antioxidant defense) and inflammation (C-reactive protein (CRP) and sCD40L) in diabetic patients submitted to PCI with stent.

Detailed Description

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Conditions

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Diabetes Mellitus Percutaneous Coronary Intervention

Keywords

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Patients with Diabetes Mellitus Submitted to Percutaneous Coronary Intervention with Stent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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standard treatment

glycemia before meals and subcutaneous regular insulin if higher than 200 mg/dl

Group Type NO_INTERVENTION

No interventions assigned to this group

Intravenous Insulin

intravenous insulin/24h guided by glycemia (Optium, Abbott) evaluated hourly, targeting values lower than 110 mg/dl

Group Type OTHER

Intravenous Insulin

Intervention Type DRUG

continuous intravenous insulin/24h guided by glycemia (Optium, Abbott) evaluated hourly, targeting values lower than 110 mg/dl

Interventions

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Intravenous Insulin

continuous intravenous insulin/24h guided by glycemia (Optium, Abbott) evaluated hourly, targeting values lower than 110 mg/dl

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with Diabetes Mellitus submitted to Percutaneous Coronary Intervention with Stent bare metal
* Age: 18-80 years old

Exclusion Criteria

* Restenosis
* Drug elution stent
* Acute coronary syndrome at last 30 days
* Use anti inflammatory, antibiotic, vitamin E
* Inflammatory disease or oncologic
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

OTHER

Sponsor Role collaborator

FIPE

UNKNOWN

Sponsor Role collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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HOSPITAL DE CLINICAS DE PORTO ALEGRE

Other Identifiers

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06036

Identifier Type: -

Identifier Source: org_study_id