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

August 27, 2009 updated by: Hospital de Clinicas de Porto Alegre

Intravenous Insulin for 24 Hours in Patients With Diabetes Mellitus Submitted to Percutaneous Coronary Intervention With Stent: Effects Upon Oxidative Stress and Inflammatory Markers

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

70

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: standard treatment
glycemia before meals and subcutaneous regular insulin if higher than 200 mg/dl
Other: Intravenous Insulin
intravenous insulin/24h guided by glycemia (Optium, Abbott) evaluated hourly, targeting values lower than 110 mg/dl
Drug: Intravenous Insulin
continuous intravenous insulin/24h guided by glycemia (Optium, Abbott) evaluated hourly, targeting values lower than 110 mg/dl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reintervention, Myocardial Infarction, Cardiovascular Death
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico
FIPE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

August 27, 2009

First Submitted That Met QC Criteria

August 27, 2009

First Posted (Estimate)

August 28, 2009

Study Record Updates

Last Update Posted (Estimate)

August 28, 2009

Last Update Submitted That Met QC Criteria

August 27, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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