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Completed

NCT Number: NCT00882492

GLP 1 for Intraoperative Glycemic Control

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GLP 1

Biological

This a continuous intravenous infusion of GLP-1 (7-36) amide infusion (1.5 pmol/kg/min)

normal saline solution placebo

Biological

This is a continuous intravenous infusion of normal saline solution as placebo (1.5 pmol/kg/min) during cardiac surgery

Primary outcomes

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

    Time frame: During surgery and 24 hours after

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: GLP

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Apr 16, 2009
Registry last updated
Feb 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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