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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide | Experimental | Patients with decreased left ventricular function undergoing elective coronary artery by-pass grafting receiving perioperatively i.v. exenatide on top of standard treatment |
|
| Control | No Intervention | Patients with decreased left ventricular function undergoing elective coronary artery by-pass grafting receiving standard treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac function - echocardiographic parameters |
| 90 days after administration of exenatide |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse effects | 90 days after administration of exenatide |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Haluzik, D.Sc. | General University Hospital, Charles University, Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General University Hospital | Prague | 128 08 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28581209 | Derived | 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. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D018754 | Ventricular Dysfunction |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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