- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01131117
비만의 태아 프로그래밍
The overall goal of this project is to understand how a mother's health at conception may influence her child's growth and development.
연구 개요
상세 설명
The purpose of this study is to determine how the mother's health prior to or at the beginning of pregnancy may influence her child's growth and development. We plan to: 1) longitudinally and simultaneously assess a true measure of body composition (lean and fat mass) of the offspring, assess body composition of both parents, and obtain dietary intake data of the mother and offspring; 2) determine endocrine and metabolic profiles of the mother at baseline (pre-conception), during pregnancy and at birth (such as insulin, glucose, leptin); 3) determine the energy expenditure and physical activity of the mother and the child; 4) determine gene expression of the placenta and umbilical cord via gene microarray and real time PCR; and 5) focused on appropriate-for-gestational age (AGA) infants (the majority of infants born from normal and overweight mothers).Accordingly, this study will provide much needed comprehensive information on the possible effect of fetal programming on the development of pediatric obesity.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Arkansas
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Little Rock, Arkansas, 미국, 72202
- Arkansas Children's Nutrition Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Healthy women
설명
Inclusion Criteria:
- healthy
- 21 years of age or older
- second pregnancy, singleton
- conceived without fertility treatments
Exclusion Criteria:
- Preexisting medical conditions
- Sexually transmitted diseases
- Medical complications during pregnancy
- Medications during pregnancy known to influence fetal growth
- Smoking, alcohol drinking
- Excessive physical activity level which could affect the outcome of interest.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
|---|
|
임산부
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Child body composition
기간: 24 months
|
lean and fat mass of the child |
24 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Child metabolism
기간: 24 months
|
monitor with a metabolic cart |
24 months
|
|
Child development
기간: 24 months
|
Monitored from 2wks up to 24 months |
24 months
|
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Child dietary intake
기간: 24 months
|
Food records for each visit will be obtained |
24 months
|
|
Placenta gene expression
기간: 9 months
|
via gene microarray and real time PCR |
9 months
|
|
Placenta protein content
기간: 9 months
|
via gene microarray and real time PCR |
9 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Aline Andres, PhD, RD, Arkansas Children's Nutrition Center
간행물 및 유용한 링크
일반 간행물
- Gilley SP, Ruebel ML, Sims C, Zhong Y, Turner D, Lan RS, Pack LM, Piccolo BD, Chintapalli SV, Abraham A, Bode L, Andres A, Shankar K. Associations between maternal obesity and offspring gut microbiome in the first year of life. Pediatr Obes. 2022 Sep;17(9):e12921. doi: 10.1111/ijpo.12921. Epub 2022 Apr 27.
- Kracht CL, Redman LM, Casey PH, Krukowski RA, Andres A. Association between Home Environment in Infancy and Child Movement Behaviors. Child Obes. 2021 Mar;17(2):100-109. doi: 10.1089/chi.2020.0319. Epub 2021 Jan 20.
- Saben JL, Sims CR, Piccolo BD, Andres A. Maternal adiposity alters the human milk metabolome: associations between nonglucose monosaccharides and infant adiposity. Am J Clin Nutr. 2020 Nov 11;112(5):1228-1239. doi: 10.1093/ajcn/nqaa216.
- Sims CR, Lipsmeyer ME, Turner DE, Andres A. Human milk composition differs by maternal BMI in the first 9 months postpartum. Am J Clin Nutr. 2020 Sep 1;112(3):548-557. doi: 10.1093/ajcn/nqaa098.
- Allman BR, Diaz EC, Andres A, Borsheim E. Divergent Changes in Serum Branched-Chain Amino Acid Concentrations and Estimates of Insulin Resistance throughout Gestation in Healthy Women. J Nutr. 2020 Jul 1;150(7):1757-1764. doi: 10.1093/jn/nxaa096.
- Diaz EC, Borsheim E, Shankar K, Cleves MA, Andres A. Prepregnancy Fat Free Mass and Associations to Glucose Metabolism Before and During Pregnancy. J Clin Endocrinol Metab. 2019 May 1;104(5):1394-1403. doi: 10.1210/jc.2018-01381.
- Porter H, West DS, Cleves MA, Saylors ME, Andres A, Krukowski RA. Association Between Household Food Environment and Excessive Gestational Weight Gain. J Womens Health (Larchmt). 2018 Aug;27(8):1064-1070. doi: 10.1089/jwh.2017.6552. Epub 2018 Apr 5.
- Krukowski RA, West DS, DiCarlo M, Cleves MA, Saylors ME, Andres A. Association of Gestational Weight Gain Expectations and Advice on Actual Weight Gain. Obstet Gynecol. 2017 Jan;129(1):76-82. doi: 10.1097/AOG.0000000000001780.
- Krukowski RA, West DS, DiCarlo M, Shankar K, Cleves MA, Saylors ME, Andres A. Are early first trimester weights valid proxies for preconception weight? BMC Pregnancy Childbirth. 2016 Nov 21;16(1):357. doi: 10.1186/s12884-016-1159-6.
- Krukowski RA, West D, DiCarlo M, Shankar K, Cleves MA, Tedford E, Andres A. A Behavioral Intervention to Reduce Excessive Gestational Weight Gain. Matern Child Health J. 2017 Mar;21(3):485-491. doi: 10.1007/s10995-016-2127-5.
- Gurung M, Chandrashekar R, Thomson JL, Landry AS, Read QD, Martinez AE, Andres A, Yeruva L. Associations between fermented dairy food intake during pregnancy and gestational weight gain, macrosomia, and gut microbiota. Clin Nutr ESPEN. 2026 Oct 12:105194. doi: 10.1016/j.clnesp.2026.105194. Online ahead of print.
- Crimmins MR, Hand M, Samuel H, Bellando J, Sims CR, Andres A, Sobik S. The Impact of Excessive Weight on Breastfeeding Intention, Initiation, and Duration. Breastfeed Med. 2023 Sep;18(9):688-695. doi: 10.1089/bfm.2023.0072.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .