Effect of GLP - 1 (7-36 Amide) on Myocardial Function Following Coronary Artery Bypass (CABG) Surgery (GLP-1 CABG)

Johns Hopkins University

Status and phase: Terminated; Phase 2

Conditions: CABG

Treatments: Drug: GLP-1 (7-36) amide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00966654

NA_00013802

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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12 participants in 2 patient groups, including a placebo group

Saline

Placebo Comparator group

Description:

Saline

Treatment:

Drug: Placebo

GLP-1

Active Comparator group

Description:

GLP-1 (7-36) amide

Treatment:

Drug: GLP-1 (7-36) amide