肥満の若者における思春期発来時期の遺伝的および環境的予測因子の自然史
肥満の若者における思春期発来時期の遺伝的および環境的要因予測に関する自然史的研究
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
...
調査の概要
詳細な説明
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)
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：NIEHS Join A Study Recruitment Group
- 電話番号：(855) 696-4347
- メール：myniehs@nih.gov
研究連絡先のバックアップ
- 名前：Natalie D Shaw, M.D.
- 電話番号：(984) 287-3716
- メール：natalie.shaw@nih.gov
研究場所
-
-
North Carolina
-
Research Triangle Park、North Carolina、アメリカ、27709
- National Institute of Environmental Health Sciences Clinical Research Unit
-
コンタクト：
- Natalie Shaw, M.D.
- 電話番号：984-287-3716
- メール：natalie.shaw@nih.gov
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Children from the community and the Obesity Weight Management Clinic within the greater Raleigh, Durham, Chapell Hill North Carolina area.
説明
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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) |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To identify predictors of pubertal timing in 5-12-year-old children with obesity
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To determine the effect of obesity on reproductive hormones and adrenarche.
時間枠：Every 6 months
|
Tanner pubic hair staging, reproductive hormones |
Every 6 months
|
協力者と研究者
捜査官
- 主任研究者：Natalie D Shaw, M.D.、National Institute of Environmental Health Sciences (NIEHS)
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 10002237
- 002237-E
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
Starting 6 months after publication, aggregated and summarized data would be made available.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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