NCT00967642

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Aug 2006

Typical duration for not_applicable diabetes-mellitus

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2009

Completed
Last Updated

August 28, 2009

Status Verified

August 1, 2009

Enrollment Period

1.9 years

First QC Date

August 27, 2009

Last Update Submit

August 27, 2009

Conditions

Diabetes MellitusPercutaneous Coronary Intervention

Keywords

Patients with Diabetes Mellitus Submitted to Percutaneous Coronary Intervention with Stent

Outcome Measures

Primary Outcomes (1)

  • Reintervention, Myocardial Infarction, Cardiovascular Death

    6 months

Study Arms (2)

standard treatment

NO INTERVENTION

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

Intravenous Insulin

OTHER

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

Drug: Intravenous Insulin

Interventions

Intravenous InsulinDRUG

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

Intravenous Insulin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Diabetes Mellitus submitted to Percutaneous Coronary Intervention with Stent bare metal
  • Age: 18-80 years old

You may not qualify if:

  • Restenosis
  • Drug elution stent
  • Acute coronary syndrome at last 30 days
  • Use anti inflammatory, antibiotic, vitamin E
  • Inflammatory disease or oncologic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 27, 2009

First Posted

August 28, 2009

Study Start

August 1, 2006

Primary Completion

July 1, 2008

Study Completion

April 1, 2009

Last Updated

August 28, 2009

Record last verified: 2009-08