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

January 31, 2016 updated by: Martin Haluzik, Charles University, Czech Republic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Prague, Czech Republic, 128 08
        • General University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective coronary artery bypass grafting operation (CABG)
  • decreased left ventricular (LV) systolic function (EF LV ≤ 50%)
  • Age 18 to 85
  • Signed informed consent
  • Females with childbearing potential have to use appropriate contraceptive measures during the whole study period and 6 months after terminating exenatide infusion (hormonal contraception or double-barrier contraception for both partners)

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)
  • cardiac surgical procedure on valve, thoracic aorta or MAZE procedure
  • pregnancy and lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Exenatide
Patients with decreased left ventricular function undergoing elective coronary artery by-pass grafting receiving perioperatively i.v. exenatide on top of standard treatment
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
NO_INTERVENTION: Control
Patients with decreased left ventricular function undergoing elective coronary artery by-pass grafting receiving standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac function - echocardiographic parameters
Time Frame: 90 days after administration of exenatide
  • cardiac chamber dimensions
  • left ventricular systolic function
  • left ventricular diastolic function
  • right ventricular systolic function
90 days after administration of exenatide

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse effects
Time Frame: 90 days after administration of exenatide
90 days after administration of exenatide

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Collaborators

Eli Lilly and Company

Investigators

  • Principal Investigator: Martin Haluzik, D.Sc., General University Hospital, Charles University, Prague

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

June 10, 2011

First Submitted That Met QC Criteria

June 13, 2011

First Posted (ESTIMATE)

June 14, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2016

Last Update Submitted That Met QC Criteria

January 31, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H8O-CY-O027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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