NCT01373216

Glucagon-like Peptide 1 Agonist Exenatide for Improved Glucose Control and Cardiac Function in Patients With Aortocoronary Bypass

EXEnatide in Patients Undergoing Coronary Artery Bypass Grafting for Improved glUcose conTrol and hemodynamIc ValuEs

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

GLP-1 has not only beneficial effects on glucose metabolism but also direct positive effects on cardiac function and metabolism in both experimental models and in patients with type 2 diabetes mellitus. Clinical data on the effects of GLP-1 agonists on cardiac function and glucose control in patients undergoing cardiac surgery are not known. Based on the results of experimental studies there is a potential for exenatide to positively influence both cardiac function and glucose metabolism in cardiac surgery patients with and without type 2 diabetes mellitus. The primary endpoint of this study is to examine whether pre- and peri-operative administration of exenatide affects perioperative hemodynamics, echocardiographic parameters, necessity of antiarrhythmic and inotropic treatment and glucose control in patients with coronary atherosclerosis and decreased left ventricular function undergoing elective coronary artery bypass grafting operation (CABG). In addition, safety and tolerability of peri-operative administration of exenatide in these patients will be examined as a secondary study objective.

Conditions

• Coronary Artery Disease
• Decreased Left Ventricular Function

Interventions

Type	Name	Description
DRUG	Exenatide	Perioperative continuous i.v. administration of exenatide lasting for 72 hours - 40 ng/min for initial 30 min, 20 ng/min for remaining 71.5 hours

Timeline

• Start date: 2011-06-01
• Primary completion: 2014-05-01
• Completion: 2014-12-01
• First posted: 2011-06-14
• Last updated: 2016-02-02

Locations

1 site across 1 country: Czechia