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
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
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
NCT ID
NCT00967642
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
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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