GLP 1 for Intraoperative Glycemic Control (GLP)

Identifying a Novel Mechanism for Perioperative Hyperglycemia Identifying a Novel Mechanism for Perioperative Hyperglycemia in Cardiac Surgery: A Role for Incretins

This is a medical research study designed to see if an infusion of a naturally occurring hormone, GLP-1, works when used to decrease blood sugar during cardiac surgery.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Hypoglycemia
• Intervention / Treatment: Biological: GLP 1; Biological: normal saline solution placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. male or female age (18-80 years),
2. ability to provide informed consent,
3. elective CABG with or without single or multivalve repair or replacement, and/ or
4. single or multivalve repair or replacement requiring CPB and sternotomy (to include subjects who are undergoing first time or redo cardiac surgery).

Exclusion Criteria:

1. concomitant surgery (e.g. carotid endarterectomy),
2. emergent surgery,
3. current steroid use,
4. insulin dependent diabetes mellitus (IDDM),
5. cardiac surgery without the use of cardiopulmonary bypass (e.g. off-pump CABG),
6. current use of positive intravenous inotropic agents,
7. serious intercurrent illness (endocarditis, sepsis, active malignancy requiring treatment) or active infection,
8. known substance abuse,
9. receipt of an investigational drug or device within 30 days prior to surgery,
10. known allergy to any of the following: GLP-1, fentanyl, midazolam, isoflurane, propofol, morphine, heparin or protamine,
11. Sulfonylurea medication administration on morning of surgery (such as, tolbutamide, tolazamide (Tolinase), chlorpropamide (Diabinese). glipizide (Glucotrol, Glucotrol XL), glyburide (Micronase, Glynase PresTabs, and DiaBeta), glimepiride (Amaryl),

12. Major end organ dysfunction defined as:

    1. Cardiac: Left ventricular ejection fraction (LVEF) < 30% by left ventriculography or echocardiogram (within 90 days prior to randomization), current use of positive intravenous inotropic agents, preoperative use of intra-aortic balloon pump (IABP), left ventricular assist device (LVAD), or extracorporeal membrane oxygenation (ECMO);
    2. Renal: preoperative serum Creatinine > 2.0 mg/dL;
    3. Hepatic: aspartate aminotransferase (AST) or alanine transferase (ALT) > 2.5 x upper limit normal;
    4. Hematologic: preoperative hematocrit (HCT) < 30%, platelet count < 100,000/mm3, history of (or family history of) bleeding or clotting disorder;
13. Patients with a history of or risk factors for acute pancreatitis (i.e. ethanol abuse, gall stones) will be excluded from this study,
14. Pregnant or breastfeeding females, or
15. any other condition that, in the opinion of the investigator, may compromise the safety of the subject or would preclude the subject from successful completion of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; This active arm is a continuous infusion of GLP-1 during cardiac surgery	Biological: GLP 1; This a continuous intravenous infusion of GLP-1 (7-36) amide infusion (1.5 pmol/kg/min)
Placebo Comparator: 2; This is a continuous infusion of normal saline solution infusion as placebo at (1.5 pmol/kg/min)	Biological: normal saline solution placebo; This is a continuous intravenous infusion of normal saline solution as placebo (1.5 pmol/kg/min) during cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome variables are plasma GLP-1 levels and plasma Glucose levels.	During surgery and 24 hours after

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: April 15, 2009
• First Submitted That Met QC Criteria: April 15, 2009
• First Posted (Estimate): April 16, 2009

Study Record Updates

• Last Update Posted (Estimate): February 16, 2012
• Last Update Submitted That Met QC Criteria: February 14, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Surgery; Cardiac; Glycemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Hypoglycemia
• Other Study ID Numbers: GLP 1 01