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

January 26, 2015 updated by: YanYan Chen, Chinese Academy of Medical Sciences, Fuwai Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Anticipated)

234

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

  • Principal Investigator: YanYan Chen, MD, Fuwai Hospital, National Center for Cardiovascular Disease

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 18, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Estimate)

January 27, 2015

Last Update Submitted That Met QC Criteria

January 26, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISSEXEN0054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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