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

CABG Clinical Trial

— GLP-1 CABG  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00966654
• Other study ID #: NA_00013802
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 26, 2009
• Last updated: March 25, 2010
• Start date: September 2008
• Est. completion date: September 2012

Study information

• Verified date: March 2010
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: September 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• CABG

Intervention

Drug:
• Placebo
1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours.
• GLP-1 (7-36) amide
1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular systolic function, Left ventricular diastolic function and Hemodynamic parameters when available: PCWP, CO, SVR, HR, MAP		2 years	No
Secondary	Insulin infusion requirements, Frequency of hypoglycemic events, Length of stay in ICU setting and Inotropic requirements at each 12 hour period after arrival to the ICU and during infusion		72 hours	No