Type 2 Diabetes
Conditions
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.
Interventions
DRUGGlucose potassium insulin solution
Enhanced glycaemic control in diabetics with glucose-potassium-insulin solution
Sponsors
British Heart Foundation
University Hospital Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United Kingdom
Contacts
Primary ContactRobert S Bonser
Backup ContactAshvini Menon
Outcome results
None listed