Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure

September 2, 2020 updated by: David Aguilar, Baylor College of Medicine

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.

Study Overview

Status

Terminated

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

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

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stable New York Heart Association (NYHA) Class II-IV heart failure symptoms for at least 4 weeks before study entry
  • Diagnosis of diastolic heart failure with a normal ejection fraction
  • Admitted to the hospital with a diagnosis of heart failure in the 12 months before study entry
  • Type 2 diabetes

Exclusion Criteria:

  • Unstable angina, heart attack, coronary artery bypass surgery, or angioplasty in the 3 months before study entry
  • Angina with exertion
  • Technically inadequate echocardiogram
  • Atrial fibrillation or atrial flutter
  • Severe valvular heart disease
  • Significant kidney insufficiency (serum creatinine greater than 2.0 mg/dL or require hemodialysis)
  • Conditions that may be associated with changes in markers of fibrosis or collagen turnover (e.g., ongoing or active rheumatological disease, requiring significant anti-inflammatory agents, immunosuppression, pulmonary fibrosis, active cancer)
  • Significant history of active substance abuse
  • Type 1 diabetes
  • Type 2 diabetes requiring chronic insulin use before study entry
  • Active thiazolidinedione (TZD) use, because TZDs have been shown to worsen volume retention and may exacerbate signs and/or symptoms of heart failure
  • Pregnant or breastfeeding
  • Hypertrophic cardiomyopathy

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
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.
Experimental: 2
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 Names:
  • Byetta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Aortic Stiffness, as Measured by the Change in the Mean Aortic Pulse Wave Velocity
Time Frame: Measured at Week 12
Measured at Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured at Week 12

Collaborators and Investigators

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

Investigators

  • Principal Investigator: David Aguilar, MD, Baylor College of Medicine

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

July 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

November 26, 2008

First Submitted That Met QC Criteria

November 26, 2008

First Posted (Estimate)

November 27, 2008

Study Record Updates

Last Update Posted (Actual)

September 4, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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