Skip to content

Trial · Interventional

CompletedPhase 3Registry data

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

Short name Executive

NCTNCT01373216 (opens ClinicalTrials.gov in a new tab)Other idH8O-CY-O027
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
38 participants (actual)
Sponsor
Charles University, Czech Republic · Other
Design
Randomized · Single masking
Countries
1 country

Czechia

Start
Jun 2011
Primary completion
May 2014
Completion
Dec 2014
First posted
14 Jun 2011 (estimated)
Last update posted
2 Feb 2016 (estimated)
Conditions
Coronary Artery Disease · Decreased Left Ventricular Function

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20112012201320142015
  1. Ph 3

    Executive

    NCT01373216

    Jun 2011 to Dec 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • ExenatideDrug

Arms2

  • 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

  • No intervention

    Control

    Patients with decreased left ventricular function undergoing elective coronary artery by-pass grafting receiving standard treatment

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Cardiac function - echocardiographic parameters

    Time frame · 90 days after administration of exenatide

    Registry description

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

Secondary outcomes(1)

  1. Number of participants with adverse effects

    Time frame · 90 days after administration of exenatide

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

5 results

Effect of continuous exenatide infusion on cardiac function and peri-operative glucose control in patients undergoing cardiac surgery: A single-blind, randomized controlled trial.

Lipš et al. 2017Diabetes, obesity & metabolismcited by 29

PMID 28581209DOI 10.1111/dom.13029PUB-28581209

Full text at the publisher5 results
Publisher pageSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.