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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00967642
• Other study ID #: 06036
• Status: Terminated
• Phase: N/A
• First received: August 27, 2009
• Last updated: August 27, 2009
• Start date: August 2006
• Est. completion date: April 2009

Study information

• Verified date: August 2009
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: April 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Percutaneous Coronary Intervention

Intervention

Drug:
• Intravenous Insulin
continuous intravenous insulin/24h guided by glycemia (Optium, Abbott) evaluated hourly, targeting values lower than 110 mg/dl

Locations

Country	Name	City	State
n/a

Sponsors (4)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reintervention, Myocardial Infarction, Cardiovascular Death		6 months