Can Enhanced Glycemic Control in Type II Diabetics Improve Myocardial Protection During Coronary Artery Bypass Grafting?
GUIDE
Can Enhanced Glycaemic Control in Type II Diabetics Improve Myocardial Protection During Coronary Artery Bypass Grafting?
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2009
CompletedFirst Posted
Study publicly available on registry
May 12, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedMay 12, 2009
May 1, 2009
3 years
May 11, 2009
May 11, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
1
ACTIVE COMPARATORAdministered with glucose potassium insulin solution to achieve euglycaemia 4.0-6.0 mmol/L
2
NO INTERVENTIONNormal departmental practice using dextrose insulin infusion
Interventions
Enhanced glycaemic control in diabetics with glucose-potassium-insulin solution
Eligibility Criteria
You may qualify if:
- Type II diabetes mellitus patients (as defined by WHO)
- Diet, oral hypoglycaemic or insulin therapy
- Undergoing elective and urgent coronary artery bypass surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Birminghamlead
- British Heart Foundationcollaborator
Study Sites (1)
University Hospital Birmingham
Birmingham, West Midlands, B15 2TH, United Kingdom
Related Publications (1)
Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.
PMID: 37526194DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 11, 2009
First Posted
May 12, 2009
Study Start
July 1, 2009
Primary Completion
July 1, 2012
Last Updated
May 12, 2009
Record last verified: 2009-05