Can Enhanced Glycemic Control in Type II Diabetics Improve Myocardial Protection During Coronary Artery Bypass Grafting?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Brief Summary

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The investigators have previously demonstrated that the administration of insulin in the form of an infusion with additional sugar and potassium may improve cardiovascular performance and reduce biochemical evidence of heart muscle injury in non-diabetic patients undergoing coronary artery surgery. The investigators now seek to demonstrate that similar benefits can be achieved in diabetic patients by administering insulin to maintain as near absolutely normal sugar levels as possible.

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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Administered with glucose potassium insulin solution to achieve euglycaemia 4.0-6.0 mmol/L

Group Type ACTIVE_COMPARATOR

Glucose potassium insulin solution

Intervention Type DRUG

Enhanced glycaemic control in diabetics with glucose-potassium-insulin solution

2

Normal departmental practice using dextrose insulin infusion

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Glucose potassium insulin solution

Enhanced glycaemic control in diabetics with glucose-potassium-insulin solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type II diabetes mellitus patients (as defined by WHO)
* Diet, oral hypoglycaemic or insulin therapy
* Undergoing elective and urgent coronary artery bypass surgery

Exclusion Criteria

* Non-diabetics
* Emergency and redo CABG
* \< 18 years
* Pregnancy
* Dialysis-dependence
* History of CVA/TIA \< 6 months
* Heart valve disease requiring surgery
* STEMI \< 3 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes