Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure
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|ClinicalTrials.gov Identifier: NCT00799435|
Recruitment Status : Terminated (Inability to recruit adequate Sample Size who met the entry criteria)
First Posted : November 27, 2008
Results First Posted : September 21, 2017
Last Update Posted : September 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Heart Failure, Diastolic||Drug: Exenatide||Phase 4|
Diastolic heart failure is a life-threatening condition that occurs when the ventricles of the heart become stiff and do not fully relax, preventing the heart from properly filling with blood. The circulation of blood then backs up, and blood collects in the body's organs, primarily the lungs. However, people with diastolic heart failure may have a normal ejection fraction, which is a measure of the amount of blood that the heart pumps out with each heart beat. Having type 2 diabetes may increase the risk of diastolic heart failure. Also, people with both heart failure and type 2 diabetes are more likely to experience poor health and even death than are people with only heart failure. It is possible that diabetes leads to increased stiffness of the ventricles and the aorta, which is the main blood vessel into which the heart empties. Exenatide, part of a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists, is a new medication that is currently used to treat elevated blood sugar levels in people with diabetes. Some studies have shown that this class of medications may have a positive effect on the heart and blood vessels. The purpose of this study is to determine the effect that exenatide has on aortic and left ventricular stiffness in people who have type 2 diabetes and diastolic heart failure.
This 12-week study will enroll adults with type 2 diabetes and diastolic heart failure with normal ejection fraction. At a baseline study visit, participants will undergo a physical examination, blood pressure and heart rate measurements, a blood collection, an echocardiogram to obtain images of the heart, and a non-invasive test that measures blood flow in the aorta. Participants will then be randomly assigned to receive either exenatide or usual care. Participants who receive exenatide will inject the medicine twice a day for 12 weeks. At Week 4, these participants will attend a study visit to adjust the medication dosage and to report any problems, and at Week 6, study staff will follow up with participants by phone. All participants will attend a study visit at Week 12 for repeat baseline testing.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment With Glucagon-Like Peptide-1 Receptor, Exenatide, in Patients With Diabetes and Heart Failure With Normal Left Ventricular Ejection Fraction|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
No Intervention: 1
Participants will receive usual care for 12 weeks. The care will be dictated by the primary physician and/or diabetologist caring for the participant. Efforts will be made to ensure that all participants receive standard measures as indicated by guidelines, with a particular emphasis on blood pressure control and glucose control.
Participants will receive exenatide for 12 weeks.
5 μg of exenatide subcutaneously twice a day for 4 weeks, followed by 10 μg of exenatide subcutaneously twice a day for an additional 8 weeks
Other Name: Byetta
- Change in Aortic Stiffness, as Measured by the Change in the Mean Aortic Pulse Wave Velocity [ Time Frame: Measured at Week 12 ]
- Changes in Left Ventricular Diastolic Stiffness, Serum Levels of Advanced Glycation End Products, Serum Biomarkers of Collagen Synthesis, and Serum Levels of Brain Natriuretic Peptide [ Time Frame: Measured at Week 12 ]Given the cessation of trials, the biomarkers analyses and diastolic function measures were not performed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799435
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||David Aguilar, MD||Baylor College of Medicine|