Can Enhanced Glycemic Control in Type II Diabetics Improve Myocardial Protection During Coronary Artery Bypass Grafting? - Full Text View

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

This study is not yet open for participant recruitment.

Verified by University Hospital Birmingham, May 2009

First Received: May 11, 2009 No Changes Posted

Sponsors and Collaborators:	University Hospital Birmingham British Heart Foundation
Information provided by:	University Hospital Birmingham
ClinicalTrials.gov Identifier:	NCT00899483

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:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment
Official Title:	Can Enhanced Glycaemic Control in Type II Diabetics Improve Myocardial Protection During Coronary Artery Bypass Grafting?

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery Diabetes

Drug Information available for: Insulin Dextrose Potassium chloride

U.S. FDA Resources

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
1: Active Comparator 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
2: No Intervention 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

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

Sponsors and Collaborators

University Hospital Birmingham

British Heart Foundation

More Information

No publications provided

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

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 11, 2009