Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Treatment With Glucagon-Like Peptide-1 Receptor, Exenatide, in Patients With Diabetes and Heart Failure With Normal Left Ventricular Ejection Fraction
People with type 2 diabetes experience heart failure more often than do people without diabetes. This may be due to increased stiffness in the heart as a result of diabetes. This study will examine whether exenatide, a medication used to treat diabetes, may have beneficial effects on the heart in people with type 2 diabetes and heart failure.
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.
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