Soft Tissue and Bone Development in Young Girls (STAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02654262
Recruitment Status : Unknown
Verified September 2016 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Recruiting
First Posted : January 13, 2016
Last Update Posted : September 26, 2016
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary:
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.

Condition or disease
Bone Development

Detailed Description:

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.

Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Obesity and Bone Development in Young Girls
Study Start Date : January 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Primary Outcome Measures :
  1. Bone development [ Time Frame: 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.

Biospecimen Retention:   Samples With DNA
serum, saliva

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 12 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02654262

Contact: Robert Blew, MS 520-626-3067
Contact: Vinson Lee, MS (520) 626-9534

United States, Arizona
University of Arizona, Nutritional Sciences Department Recruiting
Tucson, Arizona, United States, 85714
Contact: Robert Blew, MS    520-626-3067   
Contact: Vinson Lee, MS    520-626-9534   
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Scott B Going, PhD University of Arizona

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Identifier: NCT02654262     History of Changes
Other Study ID Numbers: HD74565
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016