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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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Left Ventricular Dysfunction
Type 2 Diabetes Mellitus
 Drug: Exenatide
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: EXEnatide in Diabetic Patients Undergoing Coronary Artery Bypass Grafting for Improved glUcose conTrol and hemodynamIc ValuEs

Resource links provided by NLM:

Drug Information available for: Exenatide
U.S. FDA Resources

Further study details as provided by Charles University, Czech Republic:

Primary Outcome Measures:
  • 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


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

Estimated Enrollment: 38
Study Start Date: June 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exenatide
Patients with left ventricular dysfunction 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 left ventricular dysfunction undergoing elective coronary artery by-pass grafting receiving standard treatment

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373216

Contacts
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

Locations
Czech Republic
General University Hospital Recruiting
Prague, Czech Republic, 128 08
Contact: Milos Mraz, M.D.     +420 224 96 28 84     milos_mraz@yahoo.co.uk    
Sponsors and Collaborators
Charles University, Czech Republic
Eli Lilly and Company
Investigators
Principal Investigator: Martin Haluzik, D.Sc. General University Hospital, Charles University, Prague
  More Information

No publications provided

Responsible Party: Prof. Martin Haluzik, M.D., D.Sc., General University Hospital, Charles University Prague
ClinicalTrials.gov Identifier: NCT01373216     History of Changes
Other Study ID Numbers: H8O-CY-O027
Study First Received: June 10, 2011
Last Updated: June 13, 2011
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013