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

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ClinicalTrials.gov Identifier: NCT00899483
Recruitment Status : Unknown
Verified May 2009 by University Hospital Birmingham.
Recruitment status was:  Not yet recruiting
First Posted : May 12, 2009
Last Update Posted : May 12, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Type 2 Diabetes Drug: Glucose potassium insulin solution

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Can Enhanced Glycaemic Control in Type II Diabetics Improve Myocardial Protection During Coronary Artery Bypass Grafting?
Study Start Date : July 2009
Estimated Primary Completion Date : July 2012


Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Administered with glucose potassium insulin solution to achieve euglycaemia 4.0-6.0 mmol/L
Drug: Glucose potassium insulin solution
Enhanced glycaemic control in diabetics with glucose-potassium-insulin solution
No Intervention: 2
Normal departmental practice using dextrose insulin infusion


Outcome Measures

Primary Outcome Measures :
  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 [ Time Frame: 3 months post CABG ]

Secondary Outcome Measures :
  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. [ Time Frame: 72 hours post CABG ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899483


Contacts
Contact: Robert S Bonser 0121 4721311 ext 2559 mailto:Robert.Bonser@uhb.nhs.uk
Contact: Ashvini Menon 07973674826 ashvini.menon@gmail.com

Locations
United Kingdom
University Hospital Birmingham Not yet recruiting
Birmingham, West Midlands, United Kingdom, B15 2TH
Principal Investigator: Robert S Bonser         
Sub-Investigator: Ashvini Menon         
Principal Investigator: Michael P Frenneaux         
Sponsors and Collaborators
University Hospital Birmingham
British Heart Foundation
More Information

Responsible Party: Professor Robert S Bonser, University Hospital Birmingham
ClinicalTrials.gov Identifier: NCT00899483     History of Changes
Other Study ID Numbers: RRK3545
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: May 12, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Pharmaceutical Solutions
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs