- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00808158
Examining the Relationship Between Tobacco Exposure, Abdominal Obesity, and Metabolic Syndrome in Adolescents (The STRONG Kids Study) (STRONG Kids)
Metabolic Syndrome in Adolescents: Contribution of Tobacco and Central Fat
Обзор исследования
Статус
Условия
Подробное описание
Metabolic syndrome is a term that is used to describe a group of risk factors for cardiovascular disease. The risk factors include obesity, insulin resistance, high cholesterol, and high blood pressure. Two of the most common risk factors for cardiovascular disease-tobacco exposure and abdominal obesity-are also known to influence the development of metabolic syndrome. Metabolic syndrome risk factors, as well as higher obesity levels, are being observed increasingly in adolescents. It is important to understand the relationship between tobacco exposure, abdominal obesity, and metabolic syndrome during early adolescence, as this time period is when lifestyle habits, including diet, exercise, and tobacco use, develop. The purpose of the study is to determine how changes in abdominal obesity and tobacco exposure among adolescents affect the development of metabolic syndrome risk factors, including glucose intolerance and increased levels of cholesterol and blood pressure.
This 3-year study will enroll children with a body mass index in the 50th to 98th percentile and one of their parents. At a baseline study visit, children and parents will complete questionnaires on health, nutrition, physical activity, smoke exposure, and stress levels. Children will undergo a blood and saliva collection; physical examination; measurements of blood pressure, height, weight, and waist circumference; a dual-energy x-ray absorptiometry (DEXA) scan to measure body fat and muscle; and skin fold measurements to measure body fat. Parents will undergo a saliva collection and measurements of blood pressure, height, weight, and waist circumference. Some children will wear an activity monitor for 7 days, and some children will complete a glucose tolerance test, which will involve an additional blood collection. Every 6 months, study researchers will contact parents to confirm the family's contact information. Once a year for 3 years, all participants will complete questionnaires and a saliva collection. Additionally, at Year 3, all participants will also undergo repeat measurements of blood pressure, height, weight, and waist circumference.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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New York
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Rochester, New York, Соединенные Штаты, 14642
- University of Rochester
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- BMI in the 50th to 98th percentile range
- Parent or caregiver must agree to participate in the study
Exclusion Criteria for All Participants:
- Inability to speak and understand English
- Family residence outside the greater Rochester area (more than 50 miles from the clinical research center)
- Family is planning to leave the greater Rochester area (move more than 50 miles from the clinical research center) in the 24 months after study entry
Exclusion Criteria for Children:
- Significant medical condition, including cystic fibrosis, type 1 or type 2 diabetes, or other conditions that could interfere with the assessment of metabolic-related outcome measures
- Tanner stage 3 or greater
- Currently taking medications that alter appetite and/or glucose metabolism
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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1
Children ages 9 to 10 years old, with a body mass index (BMI) in the 50th to 98th percentile range
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
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Baseline association between tobacco exposure, abdominal obesity, adiponectin, and metabolic syndrome components
Временное ограничение: Measured at baseline
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Measured at baseline
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
---|---|
Temporal change in abdominal obesity, adiponectin, and metabolic syndrome components, as correlated with level of tobacco exposure
Временное ограничение: Measured at Years 1, 2, and 3
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Measured at Years 1, 2, and 3
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Stephen R. Cook, MD, MPH, University of Rochester
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 612
- R01HL083056-01 (Грант/контракт NIH США)
- HL086946-02
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .