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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University Hospital Birmingham.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
British Heart Foundation
Information provided by:
University Hospital Birmingham
ClinicalTrials.gov Identifier:
NCT00899483
First received: May 11, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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 Intervention
Type 2 Diabetes
Drug: Glucose potassium insulin solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Can Enhanced Glycaemic Control in Type II Diabetics Improve Myocardial Protection During Coronary Artery Bypass Grafting?

Resource links provided by NLM:


Further study details as provided by University Hospital Birmingham:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2009
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Professor Robert S Bonser, University Hospital Birmingham
ClinicalTrials.gov Identifier: NCT00899483     History of Changes
Other Study ID Numbers: RRK3545
Study First Received: May 11, 2009
Last Updated: May 11, 2009
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Pharmaceutical Solutions
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014