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

NCT ID: NCT01373216

Last Updated: 2016-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2014-12-31

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 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.

Conditions

Coronary Artery Disease; Decreased Left Ventricular Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exenatide

Patients with decreased left ventricular function undergoing elective coronary artery by-pass grafting receiving perioperatively i.v. exenatide on top of standard treatment

Group Type: EXPERIMENTAL

Exenatide

Intervention Type: DRUG

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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Charles University, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Martin Haluzik

Prof. Martin Haluzik, MD DSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Haluzik, D.Sc.

Role: PRINCIPAL_INVESTIGATOR

General University Hospital, Charles University, Prague

Locations

General University Hospital

Prague, , Czechia

Countries

Czechia

References

Lips M, Mraz M, Klouckova J, Kopecky P, Dobias M, Krizova J, Lindner J, Diamant M, Haluzik M. Effect of continuous exenatide infusion on cardiac function and peri-operative glucose control in patients undergoing cardiac surgery: A single-blind, randomized controlled trial. Diabetes Obes Metab. 2017 Dec;19(12):1818-1822. doi: 10.1111/dom.13029. Epub 2017 Jul 31.

Reference Type: DERIVED

PMID: 28581209 (View on PubMed)

Other Identifiers

H8O-CY-O027

Identifier Type: -

Identifier Source: org_study_id