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

This study has been terminated.
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
FIPE
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00967642
First received: August 27, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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 Intervention
Diabetes Mellitus
Percutaneous Coronary Intervention
Drug: Intravenous Insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

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

Estimated Enrollment: 70
Study Start Date: August 2006
Study Completion Date: April 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Marco Vugman Wainstein/MD, HOSPITAL DE CLINICAS DE PORTO ALEGRE
ClinicalTrials.gov Identifier: NCT00967642     History of Changes
Other Study ID Numbers: 06036
Study First Received: August 27, 2009
Last Updated: August 27, 2009
Health Authority: Brazil: Ministry of Health

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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014