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临床试验/NCT00808158
NCT00808158已完成不适用

Metabolic Syndrome in Adolescents: Contribution of Tobacco and Central Fat

University of Rochester1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
117
试验地点
1
主要终点
Baseline association between tobacco exposure, abdominal obesity, adiponectin, and metabolic syndrome components

研究概览

简要总结

Metabolic syndrome is a term that describes a group of conditions that increase the risk of cardiovascular disease. The conditions include high blood pressure, obesity, and high cholesterol. This study will examine how changes in tobacco exposure and weight can affect the risk of developing metabolic syndrome among adolescents.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
9 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Baseline association between tobacco exposure, abdominal obesity, adiponectin, and metabolic syndrome components

时间窗: Measured at baseline

次要结局

  • Temporal change in abdominal obesity, adiponectin, and metabolic syndrome components, as correlated with level of tobacco exposure(Measured at Years 1, 2, and 3)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen Cook

Associate Professor

University of Rochester

研究点 (1)

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