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GLP 1 for Intraoperative Glycemic Control (GLP)

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ClinicalTrials.gov Identifier: NCT00882492
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : February 16, 2012
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Hyperglycemia Hypoglycemia Biological: GLP 1 Biological: normal saline solution placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia
U.S. FDA Resources

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



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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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): NCT00882492


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

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00882492     History of Changes
Other Study ID Numbers: GLP 1 01
First Posted: April 16, 2009    Key Record Dates
Last Update Posted: February 16, 2012
Last Verified: February 2012

Keywords provided by University of Pennsylvania:
Cardiac
Surgery
Glycemia

Additional relevant MeSH terms:
Hypoglycemia
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Pharmaceutical Solutions
Glucagon-Like Peptide 1
Glucagon
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents