Una storia naturale dei predittori genetici e ambientali del tempismo puberale tra i giovani con obesità
Background:
Obesity affects 1 in 5 children in the United States. Childhood obesity often persists into adolescence and adulthood. It can also raise the risk of sleep apnea, fatty liver disease, and fluid buildup in the brain and lead to early-onset puberty. This natural history study will explore how factors such as genes, hormones, diet, and chemical exposures affect puberty in children with obesity.
Objective:
To learn which factors predict the early start of puberty in children with obesity vs those of normal weight.
Eligibility:
Children aged 5 to 7 years with obesity or of normal weight.
Design:
Participants will have clinic visits every 6 months until they reach age 12.
Each clinic visit will include these tests and procedures:
A physical exam.
Collection of blood, urine, and saliva samples. Some samples will be used for genetic tests.
Questions about medical history and medications and supplements.
A questionnaire about their physical activity over the previous week.
A silicone wrist band. Participants will wear a soft wristband for a week prior to each visit. It will tell researchers what chemicals the children were exposed to during that time.
Breast ultrasound, for girls. A gel will be applied, and a wand will be pressed against the skin. The wand uses sound waves to see the tissue inside the breast.
DXA whole body scan. Once a year, participants will have a DXA (dual energy X-ray absorptiometry) scan. This scan measures the amount of bone, muscle, and fat in the body.
Optional food diary. Parents may record everything the participant eats for two 24-hour periods
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Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Study Description:
This is a longitudinal study to predict pubertal timing in 5-12-year-old girls and boys with obesity. We hypothesize that: 1) Children with obesity with exposure to estrogenic environmental compounds will demonstrate earlier puberty than those without such an exposure. 2) A polygenic risk score (PRS) of alleles that confer risk for voice break in boys will associate with age at Tanner II pubertal development in boys with obesity. 3) A polygenic risk score (PRS) of alleles that confer risk for menarche in girls will associate with age at stage II pubertal development in girls with obesity. 4) Children with obesity who demonstrate a decrease in BMI percentile of > 5 percentage points will demonstrate later stage II pubertal development than children with no change or an increase in BMI percentile but will demonstrate earlier pubertal development than peers of normal weight.
Objectives:
- Primary Objective: To identify predictors of pubertal timing in 5-12-year old children with obesity.
- Secondary Objectives: To determine the effect of obesity on reproductive hormones and adrenarche.
Endpoints:
- Primary Endpoint: pubertal markers by questionnaire, physical exam (testicular volume, breast development), and ultrasound (breast morphological stage). Pubertal development will be defined as breast morphological stage B and a testicular volume of 4 cc.
- Secondary Endpoints: Tanner pubic hair staging, reproductive hormones (luteinizing hormone (LH), Follicle-stimulating hormone (FSH), estradiol, total testosterone, dehydroepiandrosterone sulfate (DHEAS), androstenedione)
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: NIEHS Join A Study Recruitment Group
- Numero di telefono: (855) 696-4347
- Email: myniehs@nih.gov
Backup dei contatti dello studio
- Nome: Natalie D Shaw, M.D.
- Numero di telefono: (984) 287-3716
- Email: natalie.shaw@nih.gov
Luoghi di studio
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North Carolina
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Research Triangle Park, North Carolina, Stati Uniti, 27709
- National Institute of Environmental Health Sciences Clinical Research Unit
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Contatto:
- Natalie Shaw, M.D.
- Numero di telefono: 984-287-3716
- Email: natalie.shaw@nih.gov
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Children from the community and the Obesity Weight Management Clinic within the greater Raleigh, Durham, Chapell Hill North Carolina area.
Descrizione
- INCLUSION CRITERIA:
To be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study, including sharing medical records
- Male or female, aged 5 to 7 years at the screening visit
- Normal weight (defined as BMI > 5th percentile and <85th percentile for age and sex) or Obese weight (defined as BMI > 95th percentile for age and sex)
- Ability of parent or guardian to understand and willingness to sign a written informed consent document. And ability of the participant (child) to provide verbal assent and/or to sign a written assent document.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Known diagnosis of syndromic/genetic form of obesity
- Current use of medications or supplements that affect reproductive hormones (e.g., estrogen, progesterone, testosterone, puberty blockers, regular use of lavender oil or tea tree oil)
- Chronic medical conditions (e.g., type 1 or type 2 diabetes, cancer, renal failure, lupus, etc.), at the discretion of the Principal Investigator
- Clinically significant abnormal laboratory values, at the discretion of the Principal Investigator
- International adoptee (associated with earlier puberty)
Individuals who do not meet the criteria for participation in this study (screen failure) because of an acute, reversible or transient medical reason may be rescreened upon reversal, improvement or stabilization of their clinical status. Participants who develop an acute, reversible or transient medical condition during the study may return upon reversal, improvement or stabilization of their clinical status.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Normal weight children
BMI > 5th percentile and <85th percentile for age and sex |
No strategies for weight loss |
|
Obese weight children
BMI > 95th percentile for age and sex |
No strategies for weight loss Pediatric Weight Management Clinic, which utilizes multiple, individualized strategies to effect weight loss (such as nutrition, behavioral therapy, exercise programs) |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
To identify predictors of pubertal timing in 5-12-year-old children with obesity
Lasso di tempo: 1. Every 6 months2. Every 6 - 12 months, investigator discretion
|
1. pubertal markers by questionnaire, physical exam (testicular volume, Tanner breast staging), and 2. ultrasound (breast morphological stage). |
1. Every 6 months2. Every 6 - 12 months, investigator discretion
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
To determine the effect of obesity on reproductive hormones and adrenarche.
Lasso di tempo: Every 6 months
|
Tanner pubic hair staging, reproductive hormones |
Every 6 months
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Natalie D Shaw, M.D., National Institute of Environmental Health Sciences (NIEHS)
Pubblicazioni e link utili
Pubblicazioni generali
- Li W, Liu Q, Deng X, Chen Y, Liu S, Story M. Association between Obesity and Puberty Timing: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2017 Oct 24;14(10):1266. doi: 10.3390/ijerph14101266.
- Ortega MT, McGrath JA, Carlson L, Flores Poccia V, Larson G, Douglas C, Sun BZ, Zhao S, Beery B, Vesper HW, Duke L, Botelho JC, Filie AC, Shaw ND. Longitudinal Investigation of Pubertal Milestones and Hormones as a Function of Body Fat in Girls. J Clin Endocrinol Metab. 2021 May 13;106(6):1668-1683. doi: 10.1210/clinem/dgab092.
- Carlson L, Flores Poccia V, Sun BZ, Mosley B, Kirste I, Rice A, Sridhar R, Kangarloo T, Vesper HW, Duke L, Botelho JC, Filie AC, Adams JM, Shaw ND. Early breast development in overweight girls: does estrogen made by adipose tissue play a role? Int J Obes (Lond). 2019 Oct;43(10):1978-1987. doi: 10.1038/s41366-019-0446-5. Epub 2019 Aug 28.
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 10002237
- 002237-E
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Deidentified/coded Individual participant data: Demographics, Clinical Data (medical history, medications, phenotypic data, questionnaire data, physical exam, lab tests), Genomic Data (DNA and RNA sequencing), Exposomic data, and Metabolomic data.
Periodo di condivisione IPD
Starting 6 months after publication, aggregated and summarized data would be made available.
Criteri di accesso alla condivisione IPD
Data could be made available for sharing upon request, with requesters securing appropriate IRB approvals, and following establishment of a data transfer agreement. @@@@@@@@@@@@WES/WGS and RNAseq data are planned to be deposited in dbGaP, a controlled access database, at the time of publication for those subjects who consented to deposit data in dbGaP. @@@@@@
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
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