- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00366990
Low Sodium Diet and Behavioral Intervention for Reversing Arterial Stiffening in Overweight Individuals (SAVE)
Clinical Trial to Reverse Early Arterial Stiffening
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Pennsylvania
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15260
- University of Pittsburgh
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: weight loss and sodium intake reduction
Behavioral and weight loss intervention, including a low sodium diet.
Study goals are a 10% weight loss, 200 minutes of moderate physical activity a week, such as walking, and a 50% reduction in sodium intake.
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Group sessions once a week for 16 weeks, bi-weekly for 16 weeks, and monthly for 16 weeks on behavioral & weight loss topics with a focus on lowering sodium intake.
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Komparator placebo: weight loss and normal sodium intake
Behavioral and weight loss intervention, with regular sodium intake.
Study goals are a 10% weight loss, 200 minutes of moderate physical activity a week, such as walking.
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Group sessions once a week for 16 weeks, bi-weekly for 16 weeks, and monthly for 16 weeks on behavioral & weight loss topics.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
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Arterial stiffness
Ramy czasowe: Measured at Month 6
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Measured at Month 6
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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
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Arterial stiffness and remodelling
Ramy czasowe: Measured at Months 6, 12 and 24
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Measured at Months 6, 12 and 24
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Endothelial function
Ramy czasowe: Measured at Months 6, 12, and 24
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Measured at Months 6, 12, and 24
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Emma Barinas-Mitchell, PhD, University of Pittsburgh
Publikacje i pomocne linki
Publikacje ogólne
- Cooper JN, Tepper P, Barinas-Mitchell E, Woodard GA, Sutton-Tyrrell K. Serum aldosterone is associated with inflammation and aortic stiffness in normotensive overweight and obese young adults. Clin Exp Hypertens. 2012;34(1):63-70. doi: 10.3109/10641963.2011.618200. Epub 2011 Oct 18.
- Cooper JN, Fried L, Tepper P, Barinas-Mitchell E, Conroy MB, Evans RW, Mori Brooks M, Woodard GA, Sutton-Tyrrell K. Changes in serum aldosterone are associated with changes in obesity-related factors in normotensive overweight and obese young adults. Hypertens Res. 2013 Oct;36(10):895-901. doi: 10.1038/hr.2013.45. Epub 2013 May 9.
- Cooper JN, Evans RW, Mori Brooks M, Fried L, Holmes C, Barinas-Mitchell E, Sutton-Tyrrell K. Associations between arterial stiffness and platelet activation in normotensive overweight and obese young adults. Clin Exp Hypertens. 2014;36(3):115-22. doi: 10.3109/10641963.2013.789045. Epub 2013 May 8.
- Cooper JN, Buchanich JM, Youk A, Brooks MM, Barinas-Mitchell E, Conroy MB, Sutton-Tyrrell K. Reductions in arterial stiffness with weight loss in overweight and obese young adults: potential mechanisms. Atherosclerosis. 2012 Aug;223(2):485-90. doi: 10.1016/j.atherosclerosis.2012.05.022. Epub 2012 May 30.
- Njoroge JN, El Khoudary SR, Fried LF, Barinas-Mitchell E, Sutton-Tyrrell K. High urinary sodium is associated with increased carotid intima-media thickness in normotensive overweight and obese adults. Am J Hypertens. 2011 Jan;24(1):70-6. doi: 10.1038/ajh.2010.113. Epub 2010 May 27.
- Lee JJ, Woodard GA, Gianaros PJ, Barinas-Mitchell E, Tepper PG, Conroy MB. Ectopic adiposity is associated with autonomic risk factors and subclinical cardiovascular disease in young adults. Obesity (Silver Spring). 2015 Oct;23(10):2030-6. doi: 10.1002/oby.21138. Epub 2015 Sep 3.
- Hughes TM, Althouse AD, Niemczyk NA, Hawkins MS, Kuipers AL, Sutton-Tyrrell K. Effects of weight loss and insulin reduction on arterial stiffness in the SAVE trial. Cardiovasc Diabetol. 2012 Sep 22;11:114. doi: 10.1186/1475-2840-11-114.
- Niemczyk NA, Catov JM, Barinas-Mitchell E, McClure CK, Roberts JM, Tepper PG, Sutton-Tyrrell K. Nulliparity is associated with less healthy markers of subclinical cardiovascular disease in young women with overweight and obesity. Obesity (Silver Spring). 2015 May;23(5):1085-91. doi: 10.1002/oby.21044. Epub 2015 Apr 10.
- Hawkins M, Gabriel KP, Cooper J, Storti KL, Sutton-Tyrrell K, Kriska A. The impact of change in physical activity on change in arterial stiffness in overweight or obese sedentary young adults. Vasc Med. 2014 Aug;19(4):257-263. doi: 10.1177/1358863X14536630. Epub 2014 May 30.
- Smith HA, Storti KL, Arena VC, Kriska AM, Gabriel KK, Sutton-Tyrrell K, Hames KC, Conroy MB. Associations between accelerometer-derived physical activity and regional adiposity in young men and women. Obesity (Silver Spring). 2013 Jun;21(6):1299-305. doi: 10.1002/oby.20308.
- Lott MP, Kriska A, Barinas-Mitchell E, Wang L, Storti K, Winger DG, Conroy MB. Impact of Lifestyle Strategies on Longer-Term Physical Activity and Weight. J Phys Act Health. 2017 Aug;14(8):606-611. doi: 10.1123/jpah.2016-0508. Epub 2017 Apr 19.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 415
- 5R01HL077525 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
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