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

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Drug: Glucose potassium insulin solution

• Registration Number: NCT00899483
• Lead Sponsor: University Hospital Birmingham

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-05
• Study First Submitted: 2009-05-11
• Study First Submitted QC: 2009-05-11
• Last Update Submitted: 2009-05-11
• Study First Posted: 2009-05-12
• Last Update Posted: 2009-05-12
• Study Start: 2009-07
• Primary Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Glucose potassium insulin solution	Administered with glucose potassium insulin solution to achieve euglycaemia 4.0-6.0 mmol/L

Primary Outcome Measures

Name	Time	Method
The difference in the mean left ventricular end-systolic volume index (LVESVI) after CABG and the amount of new permanent injury detected in the late CMRI study	3 months post CABG

Secondary Outcome Measures

Name	Time	Method
Glycaemic control will be assessed 2 hours pre-operatively and 72 hours post-operatively. Measurement timings will be standardized allowing comparison of glycaemic control during different time-periods.	72 hours post CABG

Trial Locations

Locations (1)

University Hospital Birmingham; 🇬🇧 Birmingham, West Midlands, United Kingdom