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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Martin Haluzik, Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT01373216
First received: June 10, 2011
Last updated: March 18, 2014
Last verified: March 2014
  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:


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: April 2014
Estimated Primary Completion Date: April 2014 (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)
  • left ventricular (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

Locations
Czech Republic
General University Hospital
Prague, Czech Republic, 128 08
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: Martin Haluzik, Prof. Martin Haluzik, MD DSc, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT01373216     History of Changes
Other Study ID Numbers: H8O-CY-O027
Study First Received: June 10, 2011
Last Updated: March 18, 2014
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
Glucagon-Like Peptide 1
Glucagon
Exenatide
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Hypoglycemic Agents

ClinicalTrials.gov processed this record on April 17, 2014