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Sponsors and Collaborators: |
Baylor College of Medicine National Institutes of Health (NIH) |
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Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00297154 |
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.
Condition | Intervention |
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Heart Failure, Congestive Metabolic Syndrome X Obesity |
Behavioral: Lifestyle Modification (diet, exercise, and behavior) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Lifestyle Modification in the Treatment of Heart Failure |
Estimated Enrollment: | 60 |
Study Start Date: | March 2005 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Must meet 3 or more of the NCEP defined criteria for metabolic syndrome
Exclusion Criteria:
Valvular heart disease:
Factors that may limit adherence to interventions or affect conduct of the trial
Contact: Melissa Brock, RN | 713-873-8772 | |
Contact: Betsy Staudinger, RN | 713-873-8772 |
United States, Texas | |
Ben Taub General Hospital | Recruiting |
Houston, Texas, United States, 77030 |
Principal Investigator: | Allison M. Pritchett, M.D. | Baylor College of Medicine |
Principal Investigator: | Douglas L Mann, M.D. | Baylor College of Medicine |
Study ID Numbers: | H-16557 |
Study First Received: | February 27, 2006 |
Last Updated: | October 13, 2006 |
ClinicalTrials.gov Identifier: | NCT00297154 History of Changes |
Health Authority: | United States: Institutional Review Board |
Heart failure, congestive Metabolic Syndrome X Obesity |
Obesity Heart Failure Metabolic Syndrome X Heart Diseases Metabolic Diseases Overweight Abdominal Obesity Metabolic Syndrome Body Weight |
Signs and Symptoms Hyperinsulinism Nutrition Disorders Overnutrition Insulin Resistance Glucose Metabolism Disorders Metabolic Disorder |
Obesity Heart Failure Metabolic Diseases Metabolic Syndrome X Heart Diseases Disease Overweight Body Weight Hyperinsulinism |
Signs and Symptoms Pathologic Processes Syndrome Nutrition Disorders Cardiovascular Diseases Overnutrition Insulin Resistance Glucose Metabolism Disorders |