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Examining the Relationship Between Tobacco Exposure, Abdominal Obesity, and Metabolic Syndrome in Adolescents (The STRONG Kids Study) (STRONG Kids)

2012年11月29日 更新者:Stephen Cook、University of Rochester

Metabolic Syndrome in Adolescents: Contribution of Tobacco and Central Fat

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.

研究概览

地位

完全的

详细说明

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.

研究类型

观察性的

注册 (实际的)

117

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • Rochester、New York、美国、14642
        • University of Rochester

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

9年 至 10年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

A community sample of 240 9- to 10-year olds with varying abdominal obesity levels (all having a waist circumference equal to or above the 50th percentile for age and gender) and varying tobacco smoke exposure levels (from none to high levels)

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
1
Children ages 9 to 10 years old, with a body mass index (BMI) in the 50th to 98th percentile range

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Baseline association between tobacco exposure, abdominal obesity, adiponectin, and metabolic syndrome components
大体时间:Measured at baseline
Measured at baseline

次要结果测量

结果测量
大体时间
Temporal change in abdominal obesity, adiponectin, and metabolic syndrome components, as correlated with level of tobacco exposure
大体时间:Measured at Years 1, 2, and 3
Measured at Years 1, 2, and 3

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Stephen R. Cook, MD, MPH、University of Rochester

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年10月1日

初级完成 (实际的)

2012年5月1日

研究完成 (实际的)

2012年5月1日

研究注册日期

首次提交

2008年12月12日

首先提交符合 QC 标准的

2008年12月12日

首次发布 (估计)

2008年12月15日

研究记录更新

最后更新发布 (估计)

2012年11月30日

上次提交的符合 QC 标准的更新

2012年11月29日

最后验证

2012年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • 612
  • R01HL083056-01 (美国 NIH 拨款/合同)
  • HL086946-02

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

代谢综合征的临床试验

  • Sanford Health
    National Ataxia Foundation; Beyond Batten Disease Foundation; Pitt Hopkins Research Foundation; Cornelia... 和其他合作者
    招聘中
    线粒体疾病 | 色素性视网膜炎 | 重症肌无力 | 嗜酸性胃肠炎 | 多系统萎缩 | 平滑肌肉瘤 | 脑白质营养不良 | 肛瘘 | 脊髓小脑性共济失调3型 | 弗里德赖希共济失调 | 肯尼迪病 | 莱姆病 | 噬血细胞性淋巴组织细胞增生症 | 脊髓小脑性共济失调1型 | 脊髓小脑性共济失调2型 | 脊髓小脑共济失调6型 | 威廉姆斯综合症 | 先天性巨结肠症 | 糖原贮积病 | 川崎病 | 短肠综合症 | 低磷血症 | Leber先天性黑蒙 | 口臭 | 贲门失弛缓症 | 多发性内分泌肿瘤 | 利综合症 | 艾迪生病 | 多发性内分泌肿瘤 2 型 | 硬皮病 | 多发性内分泌肿瘤 1 型 | 多发性内分泌肿瘤 2A 型 | 多发性内分泌肿瘤 2B 型 | 非典型溶血性尿毒症综合征 | 胆道闭锁 | 痉挛性共济失调 | WAGR综合症 | 无虹膜 | 短暂性失忆症 | 马尾综合症 | Refsum 疾病 | 复发性呼吸... 及其他条件
    美国, 澳大利亚
3
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