- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07437976
비만 청소년의 사춘기 시기에 대한 유전적 및 환경적 예측 인자의 자연사
비만 청소년의 사춘기 시기에 대한 유전적 및 환경적 예측인자의 자연사
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
...
연구 개요
상세 설명
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)
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: NIEHS Join A Study Recruitment Group
- 전화번호: (855) 696-4347
- 이메일: myniehs@nih.gov
연구 연락처 백업
- 이름: Natalie D Shaw, M.D.
- 전화번호: (984) 287-3716
- 이메일: natalie.shaw@nih.gov
연구 장소
-
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North Carolina
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Research Triangle Park, North Carolina, 미국, 27709
- National Institute of Environmental Health Sciences Clinical Research Unit
-
연락하다:
- Natalie Shaw, M.D.
- 전화번호: 984-287-3716
- 이메일: natalie.shaw@nih.gov
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Children from the community and the Obesity Weight Management Clinic within the greater Raleigh, Durham, Chapell Hill North Carolina area.
설명
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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) |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
To identify predictors of pubertal timing in 5-12-year-old children with obesity
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
To determine the effect of obesity on reproductive hormones and adrenarche.
기간: Every 6 months
|
Tanner pubic hair staging, reproductive hormones |
Every 6 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Natalie D Shaw, M.D., National Institute of Environmental Health Sciences (NIEHS)
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 10002237
- 002237-E
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
IPD 공유 기간
Starting 6 months after publication, aggregated and summarized data would be made available.
IPD 공유 액세스 기준
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. @@@@@@
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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