Overview
Efficacy and Mechanism of Exenatide on Improving Heart Function in Type 2 Diabetes With Heart Failure Patients
Status:
Unknown status
Unknown status
Trial end date:
2016-12-01
2016-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The study evaluates the efficacy of heart function improvements in type 2 diabetes and heart failure patients with exenatide, and also investigates the mechanisms of exenatide improving heart function.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Chinese Academy of Medical Sciences, Fuwai HospitalTreatments:
Exenatide
Criteria
Inclusion Criteria:1. Diagnosed Type 2 diabetes mellitus
2. HbA1c 7%-10% and Fasting plasma glucose(FBG) <10mmol/L
3. Age 18-65 years
4. NT-proBNP level≥ 450 pg/ml
5. Left ventricular ejection fraction (LVEF)<40%
Exclusion Criteria:
1. Uncorrected primary vascular disease
2. congenital heart disease
3. Left ventricular outflow obstruction
4. Myocarditis
5. Aneurysm
6. uncontrolled severe arrhythmia
7. cardiogenic shock
8. unstable angina, or acute myocardial infarction
9. Severe primary hepatic, renal, or hematologic disease
10. Cr>194.5 mmol/l or K+>5.5 mmol/l
11. Systolic blood pressure (SBP) ≥180mm Hg or diastolic blood pressure (DBP) ≥110mm Hg
12. Alanine aminotransferase (ALT) >3 times the upper normal limit
13. Patients were likely to undergo coronary artery bypass graft surgery during the
following 4 weeks
14. Patients had undergone or were likely to undergo cardiac resynchronization therapy
15. Pregnant or lactating known
16. Suspected to be allergic to the study drugs
17. Use dipeptidyl peptidase-4 (DPP-4) or glucagon-like peptide-1 (GLP-1) drug in 3 months
18. Hyperthyroidism and Hypothyroidism
19. Tumor
20. Received another investigational drug within 30 days prior to randomization
21. Severe mental health condition or other uncontrolled systemic disease.