Assessment of glycemic compensation and hemodynamic parameteres in patients after administration of GLP-1 agonist exenatid during and after the implantation of aortocoronary by-pass.

Phase 1

Conditions: Patients with elective coronary artery bypass grafting with LV systolic dysfunction (EF LV = 50%)
MedDRA version: 14.1Level: PTClassification code 10011077Term: Coronary artery bypassSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1Level: HLTClassification code 10012602Term: Diabetes mellitus (incl subtypes)System Organ Class: 10014698 - Endocrine disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2010-023839-42-CZ

Lead Sponsor: General University Hospital in Prague

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- elective coronary artery bypass grafting operation (CABG) and/or valvuloplasty
- LV systolic dysfunction (EF LV = 50%)
- Age 18 - 85 years
- 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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

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
- 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
- diabetic ketoacidosis
- pregnancy and lactation