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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2010 by Johns Hopkins University.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT00966654

First received: August 26, 2009

Last updated: March 25, 2010

Last verified: March 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

August 26, 2009

Last Updated Date

March 25, 2010

Start Date ^ICMJE

September 2008

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Left ventricular systolic function, Left ventricular diastolic function and Hemodynamic parameters when available: PCWP, CO, SVR, HR, MAP [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00966654 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

CABG

Intervention ^ICMJE

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

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

Other Name: GLP-1

Study Arm (s)

Placebo Comparator: Saline
Saline

Intervention: Drug: Placebo
Active Comparator: GLP-1
GLP-1 (7-36) amide

Intervention: Drug: GLP-1 (7-36) amide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2012

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00966654

Other Study ID Numbers ^ICMJE

NA_00013802

Has Data Monitoring Committee

Responsible Party

Dariush Elahi, PhD, Johns Hopkins University School of Medicine

Study Sponsor ^ICMJE

Johns Hopkins University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Dariush Elahi, PhD

Johns Hopkins University

Information Provided By

Johns Hopkins University

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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