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

Phase 2

Terminated

• Conditions: CABG
• Interventions: Drug: Placebo; Drug: GLP-1 (7-36) amide

• Registration Number: NCT00966654
• Lead Sponsor: Johns Hopkins University

Brief 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.

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 Timeline

• Study Start: 2008-09
• Primary Completion: 2009-08
• Study First Submitted: 2009-08-26
• Study First Submitted QC: 2009-08-26
• Study First Posted: 2009-08-27
• Study Completion: 2012-09
• Results First Submitted: 2017-05-01
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-29
• Last Update Submitted: 2017-06-29
• Results First Posted: 2017-07-12
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Placebo	Saline
GLP-1	GLP-1 (7-36) amide	GLP-1 (7-36) amide

Primary Outcome Measures

Name	Time	Method
Left Ventricular Systolic Function: Pulmonary Capillary Wedge Pressure	2 years

Secondary Outcome Measures

Name	Time	Method
Insulin Infusion Requirements	72 hours

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States