GLP 1 for Intraoperative Glycemic Control

NCT00882492 | Completed Phase 1 DMC

• 1 other identifier: GLP 1 01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperglycemia; Hypoglycemia

Keywords

Cardiac; Surgery; Glycemia

Outcome Measures

Primary Outcomes (1)

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

  During surgery and 24 hours after

Study Arms (2)

1

ACTIVE COMPARATOR

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

Biological: GLP 1

2

PLACEBO COMPARATOR

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

Biological: normal saline solution placebo

Interventions

GLP 1 BIOLOGICAL

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

1

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Hyperglycemia; Hypoglycemia

Interventions

Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 16, 2009
• Study Start: December 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: February 16, 2012

Record last verified: 2012-02

Locations

US (1)