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Soft Tissue and Bone Development in Young Girls (STAR)

Obesity and Bone Development in Young Girls

Obesity during adolescence, a critical time for bone development, may impair mineral accrual and reduce bone strength, leading to greater fracture risk during adolescence and later in life. This study seeks to determine the effect of obesity and accompanying metabolic changes (insulin resistance and inflammation) on bone mineral accrual and related changes in structure and strength in young girls. The information is critical to developing effective prevention strategies to counter the linked risks of obesity and osteoporosis, both major public health concerns.

研究概览

地位

完全的

条件

详细说明

The pediatric obesity epidemic continues unabated. Its cardio-metabolic complications are undisputed, including inflammation, insulin resistance (IR), glucose intolerance and greater prevalence of type 2 diabetes (T2D) in youth. We contend an equally serious consequence of these obesity co-morbidities is their detrimental effects on bone development during adolescence, a critical time for mineral accrual and architectural modeling that underlies bone strength and fracture risk. This proposition has received little attention and the sparse results are mixed, with reports of augmented and impaired mineralization. In contrast, animal data demonstrates reduced mineral accrual and compromised architecture with insulin resistance and chronic inflammation. The conflicting results in youth are likely due to mixed samples and analyses that commingle obese youth with metabolic complications with so called metabolically healthy obese youth and the use of technology (i.e., dual energy x-ray absorptiometry, DXA) to measure bone outcomes that is confounded by the very changes that investigators seek to detect. We posit that the positive mechanical effect of excess adiposity on bone is countered by chronic low-grade inflammation and IR so that obese youth with these metabolic complications suffer impaired bone development whereas obesity in otherwise metabolically healthy youth augments development. A thorough understanding of the effects of adiposity and its co-morbidities on bone development is crucial to the development of efficacious interventions aimed at maximal mineral accrual and bone modeling. Thus, we propose primary aims designed to clarify the effects of obesity, insulin resistance and inflammation on bone around the time of peak height velocity. Adipose tissue (AT) distribution undoubtedly matters, especially abdominal visceral AT and skeletal muscle fat content, both strongly related to insulin resistance. Failure to characterize fat distribution is another important limitation of past studies. Consequently we will assess the effect of visceral AT and skeletal muscle fat along with whole body fatness and propose secondary aims designed to develop safe, cost effective methods that we and others can use for estimating AT distribution, a critical component of risk that has rarely been studied in youth relative to bone development.

Primary Aims:

  1. Assess the associations of total and regional adiposity (visceral AT and leg muscle fat content), insulin resistance, and inflammation with bone mass, density, structure and strength in normal weight, overweight, and obese pre-menarcheal girls
  2. Assess the effects of total and regional adiposity, insulin resistance, and inflammation on bone development (i.e., 2 year changes in bone parameters) in normal weight and obese pre-menarcheal girls.

研究类型

观察性的

注册 (实际的)

358

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

    • Arizona
      • Tucson、Arizona、美国、85714
        • University of Arizona, Nutritional Sciences Department

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 12年 (孩子)

接受健康志愿者

是的

取样方法

非概率样本

研究人群

Girls across obese (n=150; BMI ≥95th age and gender-specific percentile), overweight (n=150; BMI> 85th percentile and <95th percentile), and normal weight (n=150; BMI< 85th percentile) categories.

描述

Inclusion Criteria:

  • healthy, female, aged 9-12 years

Exclusion Criteria:

  • diagnosis of diabetes
  • taking medications that alter body composition and bone mineral accrual
  • physical disability that limits physical activity
  • learning disability that would limit completion of questionnaires

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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Bone development
大体时间:2 years
Baseline cross-sectional (N=450) and longitudinal changes over 2 years (N=150) in bone mass, density, structure and strength, measured by peripheral quantitative computed tomography (pQCT) and dual-energy X-ray absorptiometry (DXA), as they relate to body composition by DXA and blood biomarkers of insulin resistance and inflammation.
2 years

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:Scott B Going, PhD、University of Arizona

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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 (实际的)

2013年1月1日

初级完成 (实际的)

2018年12月31日

研究完成 (实际的)

2018年12月31日

研究注册日期

首次提交

2016年1月11日

首先提交符合 QC 标准的

2016年1月12日

首次发布 (估计的)

2016年1月13日

研究记录更新

最后更新发布 (实际的)

2026年5月11日

上次提交的符合 QC 标准的更新

2026年5月7日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • HD74565

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