Type 2 DiabetesGUIDENCT00899483
Can Enhanced Glycemic Control in Type II Diabetics Improve Myocardial Protection During Coronary Artery Bypass Grafting?
A study testing Glucose potassium insulin solution in people with Type 2 Diabetes, run by University Hospital Birmingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Glucose potassium insulin solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2009to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type II diabetes mellitus patients (as defined by WHO)
- Diet, oral hypoglycaemic or insulin therapy
- Undergoing elective and urgent coronary artery bypass surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Birmingham
Birmingham, West Midlands, B15 2TH
Robert S Bonser
Ashvini Menon
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Glucose potassium insulin solution
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose potassium insulin solutionDrug
Enhanced glycaemic control in diabetics with glucose-potassium-insulin solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Administered with glucose potassium insulin solution to achieve euglycaemia 4.0-6.0 mmol/L Receives: Drug: Glucose potassium insulin solution |
| 2 | No intervention | Normal departmental practice using dextrose insulin infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 72 hours post CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899483
- Sponsor's protocol ID
- RRK3545
- Acronym
- GUIDE
- Status last verified
- May 2009
- First submitted
- 11 May 2009
- Last updated
- 12 May 2009
- Results posted
- No
Publications
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.
PubMed 37526194
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Enhanced Glycaemic Control in Type II Diabetics Improve Myocardial Protection During Coronary Artery Bypass Grafting?
- ClinicalTrials.gov ID
- NCT00899483
- Acronym / sponsor ID
- GUIDE / RRK3545
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital BirminghamUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- Jul 2009
- Primary completion
- Jul 2012 (estimated)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Glucose potassium insulin solutionAdministered with glucose potassium insulin solution to achieve euglycaemia 4.0-6.0 mmol/L |
| 2 | No intervention | –Normal departmental practice using dextrose insulin infusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type II diabetes mellitus patients (as defined by WHO)
- Diet, oral hypoglycaemic or insulin therapy
- Undergoing elective and urgent coronary artery bypass surgery
Key exclusion criteria (8 listed)
- Non-diabetics
- Emergency and redo CABG
- < 18 years
- Pregnancy
- Dialysis-dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose potassium insulin solutionEnhanced glycaemic control in diabetics with glucose-potassium-insulin solution | Drug | 1 |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2009.
- Derived from this study: PubMed 37526194Bellon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose potassium insulin solution in people with Type 2 Diabetes, run by University Hospital Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert S Bonser (0121 4721311 ext. 2559, mailto:Robert.Bonser@uhb.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00899483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2009.