Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00966654
Recruitment Status : Terminated (PI left JHU)
First Posted : August 27, 2009
Results First Posted : July 12, 2017
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
CABG Drug: Placebo Drug: GLP-1 (7-36) amide Phase 2

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of GLP - 1 (7-36 Amide) on Myocardial Function Following Coronary Artery Bypass Surgery
Actual Study Start Date : September 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: Saline
Saline
 Drug: Placebo
1.5 pmol/kg/min (5 ng/kg/min) saline infused continuously over 72 hours.
Other Name: Saline
Active Comparator: GLP-1
GLP-1 (7-36) amide
 Drug: GLP-1 (7-36) amide
1.5 pmol/kg/min (5 ng/kg/min) GLP-1 infused continuously over 72 hours.
Other Name: GLP-1


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Left Ventricular Systolic Function: Pulmonary Capillary Wedge Pressure [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Insulin Infusion Requirements [ Time Frame: 72 hours ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966654


Locations
Layout table for location information
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Investigators
Layout table for investigator information
Principal Investigator: Dariush Elahi, PhD Johns Hopkins University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00966654    
Other Study ID Numbers: NA_00013802
First Posted: August 27, 2009    Key Record Dates
Results First Posted: July 12, 2017
Last Update Posted: July 12, 2017
Last Verified: June 2017
Keywords provided by Johns Hopkins University:
CABG
Cardiac Surgical Patient
Additional relevant MeSH terms:
Layout table for MeSH terms
Glucagon-Like Peptide 1
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs