The Effect of Diet and Exercise in Heart Failure
NCT00297154 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2020-03-03
Summary
A growing number of people in this country are overweight or obese. This is concerning as increasing weight has been shown to increase the risk of developing heart failure. However, there is also research to suggest that in people who already have heart failure, heavier people live longer. So, how does being overweight put a person at risk for heart failure, but once they have heart failure, protect them? There is no clear explanation for this dilemma.
People who are obese commonly have other diseases, such as high blood pressure, high cholesterol, and diabetes, that increase the risk of developing heart disease. It is this group of diseases that is referred to as "The Metabolic Syndrome." People with the metabolic syndrome also have increased levels of inflammation and clotting proteins in their blood stream. Current treatment of the metabolic syndrome involves using medications for cholesterol, blood pressure, and diabetes. Diet and exercise are also commonly recommended.
"Lifestyle intervention programs" are programs that help people lose weight by changing their eating habits and exercise / activity routines. Weight loss and exercise have been shown to lower the risk of developing diabetes and improve diabetes control, improve cholesterol abnormalities, and lower blood pressure. These programs have not previously included heart failure patients, however.
We hypothesize that using a lifestyle intervention program in addition to the usual medications for heart failure will result in improved symptoms of heart failure and control of the metabolic syndrome.
This study will be the first research study to look at the use of diet and exercise in treating heart failure patients who are overweight / obese with "the metabolic syndrome." The study will last 6 months. From this study we hope to learn whether diet and exercise is helpful in treating heart failure patients who are overweight. Specifically, the study will look at the short term effects on cardiac risk factors (blood pressure, cholesterol, blood sugar), heart failure symptoms, and exercise capacity.
Conditions
- Heart Failure, Congestive
- Metabolic Syndrome X
- Obesity
Interventions
- BEHAVIORAL
-
Lifestyle Modification (diet, exercise, and behavior)
Patients recieve weekly sessions with dietician, replace 2 meals/day with meal replacement beverage, and initiate a walking program.
Sponsors & Collaborators
-
National Center for Research Resources (NCRR)
collaborator NIH -
Baylor College of Medicine
lead OTHER
Principal Investigators
-
Allison M. Pritchett, M.D. · Baylor College of Medicine
-
Douglas L Mann, M.D. · Baylor College of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-03-31
- Primary Completion
- 2009-06-30
- Completion
- 2009-06-30
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