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

Type 2 Diabetes Clinical Trial

— GUIDE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00899483
• Other study ID #: RRK3545
• Status: Not yet recruiting
• Phase: N/A
• First received: May 11, 2009
• Last updated: May 11, 2009
• Start date: July 2009

Study information

• Verified date: May 2009
• Source: University Hospital Birmingham
• Contact: Robert S Bonser
• Phone: 0121 4721311
• Email: mailto:Robert.Bonser[@]uhb.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• Glucose potassium insulin solution
Enhanced glycaemic control in diabetics with glucose-potassium-insulin solution

Locations

Country	Name	City	State
United Kingdom	University Hospital Birmingham	Birmingham	West Midlands

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Birmingham	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No