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Role of Cardiometabolic Risk Factors in Childhood Bone Development

18. november 2019 opdateret af: Norman Pollock, Augusta University

Role of Cardiometabolic Risk Factors in Childhood Bone Development (Healthy Heart 'N' Bones Study)

The proposed research brings together complementary expertise to systematically elucidate the longitudinal effects of (1) total and regional body fat and (2) the metabolic impairment that accompanies obesity on bone development during growth. The contribution of this research will be significant because it will provide a solid foundation for understanding the influence of fat (total and regional distribution) on overall bone strength, and whether insulin resistance, beta-cell dysfunction, abnormal lipids, and inflammation could be underpinning factors in the fat-bone strength relationship via effects on bone modeling activity. This knowledge will provide critical information needed to maximize potential therapeutic interventions to counter the linked risks of obesity and osteoporosis, both major public health concerns.

Studieoversigt

Status

Ukendt

Intervention / Behandling

Detaljeret beskrivelse

The overall goal of this study is to clarify the relationship of adiposity with bone development during adolescence, and to explicate the mechanisms that regulate the effect of excess adiposity on bone. In this effort, we will conduct a 2-year longitudinal study in 400 children and adolescents aged 9-15 years. Using the peak adolescent growth period as a model for probing determinants of bone health may allow for a clearer picture of the processes that regulate bone development, as these processes are highly active at this growth stage. Unlike other studies with surrogates for adiposity, we plan to measure total and central adiposity directly, using dual energy X-ray absorptiometry (DXA) and magnetic resonance imaging. Both bone quantity and bone quality, the two principal determinants of bone strength, will be assessed by peripheral quantitative computed tomography (pQCT) at weight-bearing (tibia) and non-weight-bearing (radius) skeletal sites. Peripheral QCT provides 3-dimensional bone measurements that are not confounded by changes in bone size, a significant confounder of most past studies, which have relied on 2-dimensional bone imaging techniques. To identify mechanistic factors, which may explain the effect of adiposity on bone development, we will measure arterial stiffness, endothelial function, and fasting levels of glucose, insulin, lipids, and C-reactive protein (CRP) to assess how vascular dysfunction, insulin resistance, abnormal lipids, and inflammation are related to bone modeling activity, as measured by serum markers of bone formation and resorption. All measurements will be assessed at baseline and after 1 and 2 years of follow-up.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

400

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Georgia
      • Augusta, Georgia, Forenede Stater, 30912
        • Rekruttering
        • Medical College of Georgia; Augusta University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

9 år til 15 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

400 children and adolescents aged 9 to 15 years

Beskrivelse

Inclusion Criteria:

  1. Otherwise healthy children and adolescents between 9 and 15 years old
  2. Subject and parent/guardian understands the study protocol and agrees to comply with it
  3. Informed Consent Form signed by the parent/guardian and assent signed by the subject

Exclusion Criteria:

  1. Subjects with (a history of) metabolic or gastrointestinal diseases including hepatic disorders
  2. Subjects presenting chronic degenerative and/or inflammatory diseases
  3. Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)
  4. Subjects receiving corticosteroid treatment
  5. Subjects using oral anticoagulants
  6. Subjects who have participated in a clinical study more recently than one month before the current study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Prospective Cohort
400 otherwise healthy children and adolescents aged 9-15 years will be recruited to participate in a 2-year longitudinal study.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Bone mineral mass
Tidsramme: Change from baseline bone mineral mass at 2 years
Measurement of bone quantity assessed by peripheral quantitative computed tomography
Change from baseline bone mineral mass at 2 years
Bone strength-strain index
Tidsramme: Change from baseline bone strength-strain index at 2 years
Measurement of bone quality assessed by peripheral quantitative computed tomography
Change from baseline bone strength-strain index at 2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serum N-terminal propeptide of type 1 procollagen (P1NP)
Tidsramme: Change from baseline P1NP at 2 years
Marker of bone formation as measured in serum
Change from baseline P1NP at 2 years
Serum C-terminal telopeptide of type 1 collagen (CTX)
Tidsramme: Change from baseline CTX at 2 years
Marker of bone resorption as measured in serum
Change from baseline CTX at 2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Norman K Pollock, Ph.D., Department of Medicine, Medical College of Georgia, Augusta University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2014

Primær færdiggørelse (Forventet)

1. december 2021

Studieafslutning (Forventet)

30. december 2021

Datoer for studieregistrering

Først indsendt

22. januar 2015

Først indsendt, der opfyldte QC-kriterier

30. januar 2015

Først opslået (Skøn)

4. februar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. november 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. november 2019

Sidst verificeret

1. november 2019

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Observationsstudie

3
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