Efficacy and Mechanism of Exenatide on Improving Heart Function in Type 2 Diabetes With Heart Failure Patients

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Efficacy and Mechanism of Exenatide on Improving Heart Function in Type 2 Diabetes With Heart Failure Patients

Conditions
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Type 2 Diabetes Mellitus, Heart Failure

Intervention / Treatment
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* Drug: Exenatide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed Type 2 diabetes mellitus HbA1c 7%-10% and Fasting plasma glucose(FBG) <10mmol/L Age 18-65 years NT-proBNP level≥ 450 pg/ml Left ventricular ejection fraction (LVEF)<40% Exclusion Criteria: Uncorrected primary vascular disease congenital heart disease Left ventricular outflow obstruction Myocarditis Aneurysm uncontrolled severe arrhythmia cardiogenic shock unstable angina, or acute myocardial infarction Severe primary hepatic, renal, or hematologic disease Cr>194.5 mmol/l or K+>5.5 mmol/l Systolic blood pressure (SBP) ≥180mm Hg or diastolic blood pressure (DBP) ≥110mm Hg Alanine aminotransferase (ALT) >3 times the upper normal limit Patients were likely to undergo coronary artery bypass graft surgery during the following 4 weeks Patients had undergone or were likely to undergo cardiac resynchronization therapy Pregnant or lactating known Suspected to be allergic to the study drugs Use dipeptidyl peptidase-4 (DPP-4) or glucagon-like peptide-1 (GLP-1) drug in 3 months Hyperthyroidism and Hypothyroidism Tumor Received another investigational drug within 30 days prior to randomization Severe mental health condition or other uncontrolled systemic disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exenatide<br>exenatide group receive exenatide (5μg, subcutaneous injection, Bid） | Drug: Exenatide<br> <br> |
| No Intervention: control group<br>control group do not receive exenatide | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in plasma NT-proBNP level after using exenatide for 4 weeks |  | 4 weeks |