GLP 1 for Intraoperative Glycemic Control

Hyperglycemia Clinical Trial

— GLP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882492
• Other study ID #: GLP 1 01
• Status: Completed
• Phase: Phase 1
• First received: April 15, 2009
• Last updated: February 14, 2012
• Start date: December 2008
• Est. completion date: May 2011

Study information

• Verified date: February 2012
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperglycemia
• Hypoglycemia

Intervention

Biological:
• GLP 1
This a continuous intravenous infusion of GLP-1 (7-36) amide infusion (1.5 pmol/kg/min)
• normal saline solution placebo
This is a continuous intravenous infusion of normal saline solution as placebo (1.5 pmol/kg/min) during cardiac surgery

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome variables are plasma GLP-1 levels and plasma Glucose levels.		During surgery and 24 hours after