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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01373216

Acronym

Executive

Enrollment

Registered

2011-06-14

Start date

2011-06-30

Completion date

2014-12-31

Last updated

2016-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Decreased Left Ventricular Function

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.

Interventions

DRUGExenatide

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Cardiac function - echocardiographic parameters	90 days after administration of exenatide	* cardiac chamber dimensions * left ventricular systolic function * left ventricular diastolic function * right ventricular systolic function

Secondary

Measure	Time frame
Number of participants with adverse effects	90 days after administration of exenatide

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026