Low Sodium Diet and Behavioral Intervention for Reversing Arterial Stiffening in Overweight Individuals



Status:Completed
Conditions:Obesity Weight Loss, Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:20 - 45
Updated:4/21/2016
Start Date:January 2007
End Date:June 2013

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Clinical Trial to Reverse Early Arterial Stiffening

Obese individuals are at risk for developing cardiovascular disease (CVD). Increasing
physical activity, losing weight, and reducing sodium intake may reverse arterial stiffness
and blood vessel damage that is linked to obesity. This study will evaluate the
effectiveness of a low sodium diet and a behavioral weight loss intervention in reducing
arterial stiffness in overweight young adults.

CVD includes diseases that affect the heart and blood vessels. Arterial stiffness, in which
arteries harden and become less flexible, increases the risk of developing CVD. Arterial
stiffness increases both with age and in certain disease states, including high blood
pressure, diabetes, and obesity. Young adults who are obese prematurely place themselves at
risk for developing arterial stiffness and CVD. Physical activity and weight loss may
reverse arterial stiffness in these individuals. Reducing sodium intake, which has been
proven to decrease blood pressure, may also improve blood vessel function and arterial
stiffness. The purpose of this study is to evaluate the effectiveness of a low sodium diet
and a behavioral weight loss intervention in reducing arterial stiffness in young,
moderately overweight individuals.

Participants will first attend a baseline study visit, at which time blood will be
collected, and height, weight, waist circumference, and blood pressure will be measured.
Questionnaires to assess medical history, physical activity levels, and dietary habits will
be completed. An ultrasound will be used to evaluate blood vessel function and arterial
stiffness. All participants will then take part in a 12-month behavioral and dietary
intervention. The intervention will emphasize increasing physical activity and decreasing
caloric intake by modifying lifestyle choices, physical and social environments, and
attitudes toward food and exercise. Participants will be randomly assigned to follow either
a low sodium diet or a normal sodium diet. During Months 1 through 4, participants will
attend weekly study visits for group counseling sessions; during Months 4 through 8, study
visits will occur once every two weeks; and during Months 8 through 12, they will occur once
a month. At each study visit, weight, waist circumference, and blood pressure will also be
measured. If necessary, individual counseling sessions will be scheduled. Participants will
also document daily physical activity and caloric intake in a diary. Baseline evaluations
will be repeated at Months 6, 12, and 24.

Inclusion Criteria:

- Body mass index (BMI) between 25 and 35

Exclusion Criteria:

- High blood pressure currently being treated with medication

- Blood pressure greater than or equal to 140/90 mm Hg on two consecutive study visits

- Diabetes, defined as either a fasting glucose test result of .126 or current use of
hypoglycemic medications

- Currently taking hyperlipidemia medication

- Currently taking vasoactive medications

- History of known atherosclerotic disease (e.g., angina, heart attack, lower extremity
arterial disease)

- Underlying inflammatory condition (e.g., systemic lupus erythematosus, rheumatoid
arthritis)

- Chronic infection

- Current participation in a formal exercise or weight loss program

- Pregnant or planning to become pregnant during the study
We found this trial at
1
site
4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Pittsburgh, PA
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