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GLP 1 for Intraoperative Glycemic Control (GLP)

Primary Purpose

Hyperglycemia, Hypoglycemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GLP 1
normal saline solution placebo
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperglycemia focused on measuring Cardiac, Surgery, Glycemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

This active arm is a continuous infusion of GLP-1 during cardiac surgery

This is a continuous infusion of normal saline solution infusion as placebo at (1.5 pmol/kg/min)

Outcomes

Primary Outcome Measures

The primary outcome variables are plasma GLP-1 levels and plasma Glucose levels.

Secondary Outcome Measures

Full Information

First Posted
April 15, 2009
Last Updated
February 14, 2012
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT00882492
Brief Title
GLP 1 for Intraoperative Glycemic Control
Acronym
GLP
Official Title
Identifying a Novel Mechanism for Perioperative Hyperglycemia Identifying a Novel Mechanism for Perioperative Hyperglycemia in Cardiac Surgery: A Role for Incretins
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Hypoglycemia
Keywords
Cardiac, Surgery, Glycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
This active arm is a continuous infusion of GLP-1 during cardiac surgery
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
This is a continuous infusion of normal saline solution infusion as placebo at (1.5 pmol/kg/min)
Intervention Type
Biological
Intervention Name(s)
GLP 1
Intervention Description
This a continuous intravenous infusion of GLP-1 (7-36) amide infusion (1.5 pmol/kg/min)
Intervention Type
Biological
Intervention Name(s)
normal saline solution placebo
Intervention Description
This is a continuous intravenous infusion of normal saline solution as placebo (1.5 pmol/kg/min) during cardiac surgery
Primary Outcome Measure Information:
Title
The primary outcome variables are plasma GLP-1 levels and plasma Glucose levels.
Time Frame
During surgery and 24 hours after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: male or female age (18-80 years), ability to provide informed consent, elective CABG with or without single or multivalve repair or replacement, and/ or single or multivalve repair or replacement requiring CPB and sternotomy (to include subjects who are undergoing first time or redo cardiac surgery). Exclusion Criteria: concomitant surgery (e.g. carotid endarterectomy), emergent surgery, current steroid use, insulin dependent diabetes mellitus (IDDM), cardiac surgery without the use of cardiopulmonary bypass (e.g. off-pump CABG), current use of positive intravenous inotropic agents, serious intercurrent illness (endocarditis, sepsis, active malignancy requiring treatment) or active infection, known substance abuse, receipt of an investigational drug or device within 30 days prior to surgery, known allergy to any of the following: GLP-1, fentanyl, midazolam, isoflurane, propofol, morphine, heparin or protamine, 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), Major end organ dysfunction defined as: 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); Renal: preoperative serum Creatinine > 2.0 mg/dL; Hepatic: aspartate aminotransferase (AST) or alanine transferase (ALT) > 2.5 x upper limit normal; Hematologic: preoperative hematocrit (HCT) < 30%, platelet count < 100,000/mm3, history of (or family history of) bleeding or clotting disorder; Patients with a history of or risk factors for acute pancreatitis (i.e. ethanol abuse, gall stones) will be excluded from this study, Pregnant or breastfeeding females, or 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.
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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GLP 1 for Intraoperative Glycemic Control

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