Heart Failure, Type 2 Diabetes Mellitus
Conditions
Brief 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.
Detailed description
The study enrolls 234 patients with type 2 diabetes and heart failure. The patients have an New York Heart Association (NYHA) functional class of II to IV, are randomly assigned to 2 groups. One group use exenatide , the other group is control group and each group has 117 patients. At the baseline, the 3rd day, the 28th day patients are required to complete the heart failure examination: plasma N-terminal pro-B-type natriuretic peptide(NT-proBNP), 6-min walking distance, echocardiographic measures, patient quality of life(MLHFQ). At the end of 4-week follow-up, we evaluate the efficacy of heart function improvements after treatment with exenatide and also investigate the mechanisms of exenatide improving heart function .
Interventions
DRUGExenatide
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in plasma NT-proBNP level after using exenatide for 4 weeks | 4 weeks |
Contacts
Primary ContactXinXing Feng, MD
Outcome results
None listed