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

What Was Tested

This registered not phased trial tested Insulin (regular human).

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.

It had two arms (groups): standard treatment (no intervention) and Intravenous Insulin (other).

The registry classes the interventions as drug.

Who Took Part

70 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients with Diabetes Mellitus submitted to Percutaneous Coronary Intervention with Stent bare metal. Age: 18-80 years old.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: drug elution stent; acute coronary syndrome at last 30 days; use anti inflammatory, antibiotic, vitamin e.

How the Study Was Run

Design: randomized, single-group and open-label.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2006-08 with completion listed for 2008-07.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 70 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.