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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00967642
Recruitment Status : Terminated
First Posted : August 28, 2009
Last Update Posted : August 28, 2009
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Information provided by:
Hospital de Clinicas de Porto Alegre

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Percutaneous Coronary Intervention Drug: Intravenous Insulin Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: standard treatment
glycemia before meals and subcutaneous regular insulin if higher than 200 mg/dl
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

Primary Outcome Measures :
  1. Reintervention, Myocardial Infarction, Cardiovascular Death [ Time Frame: 6 months ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Marco Vugman Wainstein/MD, HOSPITAL DE CLINICAS DE PORTO ALEGRE Identifier: NCT00967642     History of Changes
Other Study ID Numbers: 06036
First Posted: August 28, 2009    Key Record Dates
Last Update Posted: August 28, 2009
Last Verified: August 2009

Keywords provided by Hospital de Clinicas de Porto Alegre:
Patients with Diabetes Mellitus Submitted to Percutaneous Coronary Intervention with Stent

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs