GLP 1 for Intraoperative Glycemic Control

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00882492
First received: April 15, 2009
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Hyperglycemia
Hypoglycemia
Biological: GLP 1
Biological: normal saline solution placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Identifying a Novel Mechanism for Perioperative Hyperglycemia Identifying a Novel Mechanism for Perioperative Hyperglycemia in Cardiac Surgery: A Role for Incretins

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • The primary outcome variables are plasma GLP-1 levels and plasma Glucose levels. [ Time Frame: During surgery and 24 hours after ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: December 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882492

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00882492     History of Changes
Other Study ID Numbers: GLP 1 01
Study First Received: April 15, 2009
Last Updated: February 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
Cardiac
Surgery
Glycemia

Additional relevant MeSH terms:
Hyperglycemia
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 26, 2014