GLP-1 Agonist Exenatide for Improved Glucose Control and Cardiac Function in Diabetic Patients With Aortocoronary Bypass (Executive)

This study is currently recruiting participants.

Verified June 2011 by Charles University, Czech Republic

Sponsor:

Collaborator:

Eli Lilly and Company

Information provided by:

Charles University, Czech Republic

ClinicalTrials.gov Identifier:

NCT01373216

First received: June 10, 2011

Last updated: June 13, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 10, 2011

Last Updated Date

June 13, 2011

Start Date ^ICMJE

June 2011

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cardiac function - echocardiographic parameters [ Time Frame: 90 days after administration of exenatide ] [ Designated as safety issue: No ]

cardiac chamber dimensions
left ventricular systolic function
left ventricular diastolic function
right ventricular systolic function

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01373216 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of participants with adverse effects [ Time Frame: 90 days after administration of exenatide ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

GLP-1 Agonist Exenatide for Improved Glucose Control and Cardiac Function in Diabetic Patients With Aortocoronary Bypass

Official Title ^ICMJE

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

Brief 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 diabetic 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 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 type 2 diabetics with coronary atherosclerosis and left ventricular dysfunction elective undergoing 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Artery Disease
Left Ventricular Dysfunction
Type 2 Diabetes Mellitus

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Exenatide
Patients with left ventricular dysfunction undergoing elective coronary artery by-pass grafting receiving perioperatively i.v. exenatide on top of standard treatment

Intervention: Drug: Exenatide
No Intervention: Control
Patients with left ventricular dysfunction undergoing elective coronary artery by-pass grafting receiving standard treatment

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2013

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

established diagnosis of type 2 diabetes mellitus treated by oral antidiabetic agents
elective coronary artery bypass grafting operation (CABG)
LV systolic dysfunction (EF LV ≤ 40%)
Age 18 to 85

Exclusion Criteria:

allergy to exenatide
allergy to insulin
mental incapacity or language barrier
use of incretin-based therapies <3 months before inclusion in the study
diabetic ketoacidosis
established autonomic neuropathy
history of acute pancreatitis or severe disease of digestive tract
renal failure (preoperative creatinine ≥ 180 umol/l)
liver failure (coagulation times more than 1.5 times higher without use of anticoagulants)
chronic intensified insulin regimen treatment (more than two insulin injections/day)
cardiac surgical procedure on valve, thoracic aorta or MAZE procedure
pregnancy and lactation

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Martin Haluzik, D.Sc.	+420 224 96 29 08	mhalu@lf1.cuni.cz
Contact: Milos Mraz, M.D.	+420 224 96 28 84	milos_mraz@yahoo.co.uk

Location Countries ^ICMJE

Czech Republic

Administrative Information

NCT Number ^ICMJE

NCT01373216

Other Study ID Numbers ^ICMJE

H8O-CY-O027

Has Data Monitoring Committee

Yes

Responsible Party

Prof. Martin Haluzik, M.D., D.Sc., General University Hospital, Charles University Prague

Study Sponsor ^ICMJE

Charles University, Czech Republic

Collaborators ^ICMJE

Eli Lilly and Company

Investigators ^ICMJE

Principal Investigator:

Martin Haluzik, D.Sc.

General University Hospital, Charles University, Prague

Information Provided By

Charles University, Czech Republic

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top