CABGPhase 2GLP-1 CABGNCT00966654
Effect of GLP - 1 (7-36 Amide) on Myocardial Function Following Coronary Artery Bypass (CABG) Surgery
A Phase 2 study testing GLP-1 (7-36) amide in people with CABG, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to see if giving a hormone called GLP-1 can improve heart function and reduce length of stay in the Cardiac Surgical Intensive Care Unit (CSICU) in people who have non-emergent coronary artery bypass graft (CABG) surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CABG
- What is being tested?
- GLP-1 (7-36) amide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Sep 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females age > 18 years of age
- Able to consent
- Scheduled for non-emergent coronary artery bypass graft (CABG)
- Have an ejection fraction < 35%
- Ischemic patients with Left Ventricular Dysfunction (LVD) who need a valve procedure with their CABG
Who cannot join
- Emergency coronary artery bypass graft surgery
- Patients with an ejection fraction > 35%
- Repeat or redo CABG patients
- Patients with a history of pancreatitis
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of GLP - 1 (7-36 Amide) on Myocardial Function Following Coronary Artery Bypass Surgery
This research is being done to see if giving a hormone called GLP-1 can improve heart function and reduce length of stay in the Cardiac Surgical Intensive Care Unit (CSICU) in people who have non-emergent coronary artery bypass graft (CABG) surgery.
Read the detailed description
After CABG surgery, a condition known as hyperglycemia or high blood sugar often occurs even in patients who have never been diagnosed with diabetes. This high blood sugar can lead to complications after surgery such as infections at the site of the incision. Additionally, if there is any cardiac muscle injury either prior to or during surgery, the injured cardiac muscle can not use glucose (the body's fuel and energy source) as well as it did prior to the injury. This reduced ability to use glucose slows the cardiac muscles ability to repair itself and provide the normal pumping force and function needed to circulate the blood throughout the body. This inability to repair itself and/or provide the normal pumping force and function can make it difficult for the patient as well as increase the length of stay required in the CSICU.
GLP-1 has the ability to lower blood sugar and help cells use glucose for fuel and energy but when the blood sugar becomes low its glucose lowering ability decreases. In this study, we want to see we want to see if GLP-1 may help keep the blood sugar within normal limits and reduce or eliminate the need for insulin. We will also see whether it will help the heart recover more quickly.
- Conditions
- CABG
- Being tested
- Placebo, GLP-1 (7-36) amide
- Keywords
- CABG, Cardiac Surgical Patient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Saline
1.5 pmol/kg/min (5 ng/kg/min) saline infused continuously over 72 hours.
GLP-1 (7-36) amideDrug
Also called GLP-1
1.5 pmol/kg/min (5 ng/kg/min) GLP-1 infused continuously over 72 hours.
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | Saline Receives: Drug: Placebo |
| GLP-1 | Active comparator | GLP-1 (7-36) amide Receives: Drug: GLP-1 (7-36) amide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Systolic Function: Pulmonary Capillary Wedge Pressure
Measured: 2 years
Secondary outcomes (1)
Insulin Infusion Requirements
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startSep 2008
- Primary completionAug 2009
- Study completionSep 2012
Why it stopped: PI left JHU
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CABGStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dariush Elahi, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966654
- Sponsor's protocol ID
- NA_00013802
- Acronym
- GLP-1 CABG
- Status last verified
- Jun 2017
- First submitted
- 26 Aug 2009
- Last updated
- 12 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of GLP - 1 (7-36 Amide) on Myocardial Function Following Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT00966654
- Acronym / sponsor ID
- GLP-1 CABG / NA_00013802
- Conditions
- CABG
- Keywords
- CABG, Cardiac Surgical Patient
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left JHU
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Sep 2008 (actual)
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Posted 12 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to see if giving a hormone called GLP-1 can improve heart function and reduce length of stay in the Cardiac Surgical Intensive Care Unit (CSICU) in people who have non-emergent coronary artery bypass graft (CABG) surgery.
Detailed description
After CABG surgery, a condition known as hyperglycemia or high blood sugar often occurs even in patients who have never been diagnosed with diabetes. This high blood sugar can lead to complications after surgery such as infections at the site of the incision. Additionally, if there is any cardiac muscle injury either prior to or during surgery, the injured cardiac muscle can not use glucose (the body's fuel and energy source) as well as it did prior to the injury. This reduced ability to use glucose slows the cardiac muscles ability to repair itself and provide the normal pumping force and function needed to circulate the blood throughout the body. This inability to repair itself and/or provide the normal pumping force and function can make it difficult for the patient as well as increase the length of stay required in the CSICU.
GLP-1 has the ability to lower blood sugar and help cells use glucose for fuel and energy but when the blood sugar becomes low its glucose lowering ability decreases. In this study, we want to see we want to see if GLP-1 may help keep the blood sugar within normal limits and reduce or eliminate the need for insulin. We will also see whether it will help the heart recover more quickly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Drug: PlaceboSaline |
| GLP-1 | Active comparator | Drug: GLP-1 (7-36) amideGLP-1 (7-36) amide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and Females age > 18 years of age
- Able to consent
- Scheduled for non-emergent coronary artery bypass graft (CABG)
- Have an ejection fraction < 35%
- Ischemic patients with Left Ventricular Dysfunction (LVD) who need a valve procedure with their CABG
Key exclusion criteria (5 listed)
- Emergency coronary artery bypass graft surgery
- Patients with an ejection fraction > 35%
- Repeat or redo CABG patients
- Patients with a history of pancreatitis
- Pregnant or lactating females
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 |
|---|---|---|
| PlaceboAlso: Saline1.5 pmol/kg/min (5 ng/kg/min) saline infused continuously over 72 hours. | Drug | Saline |
| GLP-1 (7-36) amideAlso: GLP-11.5 pmol/kg/min (5 ng/kg/min) GLP-1 infused continuously over 72 hours. | Drug | GLP-1 |
Primary outcome
Left Ventricular Systolic Function: Pulmonary Capillary Wedge Pressure
Time frame: 2 years
1 secondary outcome
Insulin Infusion Requirements
Time frame: 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for CABG
RecruitingPhase 3
Influence of Superficial Parasternal Intercostal Plane Block on Internal Thoracic Artery Caliber to Facilitate Surgical Harvesting in CABG
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Active, not recruitingPhase 4
Pilot Trial of Colchicine for Graft Failure in CABG
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RecruitingObservational study
Prospective Study Protocol for Multiparametric PCCT Assessment of Early Ventricular Outcomes After CABG
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Photobiomodulation in Coronary Artery Bypass Grafting With No-Touch vs Conventional Saphenous Vein Harvesting.
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Risk Stratification of MACE in Heart Failure Patients Who Undergoing CABG
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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.
Dariush Elahi, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GLP-1 (7-36) amide in people with CABG, run by Johns Hopkins University at 1 site in United States.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 12 Jul 2017. 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 States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Systolic Function: Pulmonary Capillary Wedge Pressure (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2017; AzTrials last refreshed its copy on 31 Oct 2026.