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

May 11, 2009 updated by: University Hospital Birmingham

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • University Hospital Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 3 months post CABG
3 months post CABG

Secondary Outcome Measures

Outcome 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.
Time Frame: 72 hours post CABG
72 hours post CABG

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Birmingham

Collaborators

British Heart Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

May 11, 2009

First Submitted That Met QC Criteria

May 11, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

May 12, 2009

Last Update Submitted That Met QC Criteria

May 11, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRK3545

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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