Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

358

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Arizona
      • Tucson, Arizona, Forente stater, 85714
        • University of Arizona, Nutritional Sciences Department

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

9 år til 12 år (Barn)

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Bone development
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Scott B Going, PhD, University of Arizona

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2013

Primær fullføring (Faktiske)

31. desember 2018

Studiet fullført (Faktiske)

31. desember 2018

Datoer for studieregistrering

Først innsendt

11. januar 2016

Først innsendt som oppfylte QC-kriteriene

12. januar 2016

Først lagt ut (Antatt)

13. januar 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • HD74565

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere