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

Primary Purpose

Diabetes Mellitus, Percutaneous Coronary Intervention

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intravenous Insulin
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Patients with Diabetes Mellitus Submitted to Percutaneous Coronary Intervention with Stent

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Other

    Arm Label

    standard treatment

    Intravenous Insulin

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Reintervention, Myocardial Infarction, Cardiovascular Death

    Secondary Outcome Measures

    Full Information

    First Posted
    August 27, 2009
    Last Updated
    August 27, 2009
    Sponsor
    Hospital de Clinicas de Porto Alegre
    Collaborators
    Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, FIPE
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00967642
    Brief Title
    Intravenous Insulin in Patients With Diabetes After Percutaneous Coronary Intervention (PCI)
    Official Title
    Intravenous Insulin for 24 Hours in Patients With Diabetes Mellitus Submitted to Percutaneous Coronary Intervention With Stent: Effects Upon Oxidative Stress and Inflammatory Markers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2009
    Overall Recruitment Status
    Terminated
    Study Start Date
    August 2006 (undefined)
    Primary Completion Date
    July 2008 (Actual)
    Study Completion Date
    April 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hospital de Clinicas de Porto Alegre
    Collaborators
    Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, FIPE

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Percutaneous Coronary Intervention
    Keywords
    Patients with Diabetes Mellitus Submitted to Percutaneous Coronary Intervention with Stent

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (false)

    8. Arms, Groups, and Interventions

    Arm Title
    standard treatment
    Arm Type
    No Intervention
    Arm Description
    glycemia before meals and subcutaneous regular insulin if higher than 200 mg/dl
    Arm Title
    Intravenous Insulin
    Arm Type
    Other
    Arm Description
    intravenous insulin/24h guided by glycemia (Optium, Abbott) evaluated hourly, targeting values lower than 110 mg/dl
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous Insulin
    Intervention Description
    continuous intravenous insulin/24h guided by glycemia (Optium, Abbott) evaluated hourly, targeting values lower than 110 mg/dl
    Primary Outcome Measure Information:
    Title
    Reintervention, Myocardial Infarction, Cardiovascular Death
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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