Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure
Primary Purpose
Diabetes Mellitus, Type 2, Heart Failure, Diastolic
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exenatide
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, Diastolic Heart Failure, Aortic Stiffness, Exenatide
Eligibility Criteria
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
Sites / Locations
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
1
2
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in Aortic Stiffness, as Measured by the Change in the Mean Aortic Pulse Wave Velocity
Secondary Outcome Measures
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
Given the cessation of trials, the biomarkers analyses and diastolic function measures were not performed.
Full Information
NCT ID
NCT00799435
First Posted
November 26, 2008
Last Updated
September 2, 2020
Sponsor
Baylor College of Medicine
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00799435
Brief Title
Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure
Official Title
Treatment With Glucagon-Like Peptide-1 Receptor, Exenatide, in Patients With Diabetes and Heart Failure With Normal Left Ventricular Ejection Fraction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Inability to recruit adequate Sample Size who met the entry criteria
Study Start Date
July 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Heart Failure, Diastolic
Keywords
Diabetes, Diastolic Heart Failure, Aortic Stiffness, Exenatide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
Participants will receive exenatide for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Exenatide
Other Intervention Name(s)
Byetta
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Aortic Stiffness, as Measured by the Change in the Mean Aortic Pulse Wave Velocity
Time Frame
Measured at Week 12
Secondary Outcome Measure Information:
Title
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
Description
Given the cessation of trials, the biomarkers analyses and diastolic function measures were not performed.
Time Frame
Measured at Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Aguilar, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure
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