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소아 비만 및 심장 대사 장애의 산전 프로그래밍

2026년 9월 23일 업데이트: Saila Koivusalo, Helsinki University Central Hospital

소아 비만과 심장 대사 장애의 산전 프로그래밍 - 산모 비만, 임신 합병증 및 산모-태아 대사체의 역할

This is a prospective 11-17 -years follow-up of two existing pregnancy cohort (PREDO) and prevention (RADIEL) studies. The main objective is to investigate the associations between maternal overweight, obesity, hypertensive disorders in pregnancy, gestational diabetes, and maternal-fetal metabolome, child's birth outcomes, and overweight and obesity and cardio metabolic health outcomes in childhood and adolescence. During this follow-up study, the mothers and their 11-17-year-old children are invited for a study visit and their cardio metabolic health is studied by many different methods.

연구 개요

상태

모병

정황

상세 설명

The study comprises two Finnish pregnancy cohort /prevention studies, in which mother-child pairs have already been followed from early pregnancy until the threshold of adolescence. During this project period the follow-up of PREDO and RADIEL mothers and children will be extended until 11-17 and 11-14 years of age, respectively. This adolescence follow-up will include detailed measurements of overweight/obesity, body composition, and cardiovascular and metabolic health as well as lifestyle factors.

Research methods:

Maternal cardiometabolic conditions during pregnancy (data available): is defined by maternal pre-pregnancy BMI extracted from the Medical Birth; gestational weight gain calculated from maternal weight at childbirth derived from antenatal cards; blood pressure and proteinuria from antenatal cards, and results of 2-h oral glucose tolerance test and diagnoses of gestational diabetes and hypertensive disorders (chronic hypertension, gestational hypertension, preeclampsia) extracted from medical records and verified by an expert jury comprising two medical doctors and a research nurse with expertise in obstetrics.
Maternal and fetal metabolome (data available): is quantified by using high-throughput proton nuclear magnetic resonance (NMR) metabolomics platform (Nightingale Health Ltd, Helsinki, Finland). In total 220 metabolites were quantified covering multiple metabolic pathways, including lipoprotein lipids and subclasses, apolipoproteins, fatty and amino acids, ketone bodies, glycolysis and gluconeogenesis-related metabolites, fluid balance and inflammation.
Child's overweight/obesity and cardiometabolic health in childhood (data available): Child's weight and height have been derived from the child health center registry with data available from birth to 7-11 years in PREDO and from birth to 5 years in RADIEL. The 24-h ambulatory blood pressure data are available in the PREDO study from the child follow-up at age 7-11 years, and in the RADIEL study from the 5-year follow-up visit.
Child's overweight/obesity and cardiometabolic health in adolescence (11-17yrs): (data entry and quality control 1/22-6/24) will include
- Body weight, height, blood pressure, pulse
- Tanner stage
- Body fat percentage (bioimpedance, InBody)
- Digital questionnaires: Background, and Assessment of the psychological development of the child: Child Behavior Checklist for Ages 6-18 (CBCL), Strengths and Difficulties Questionnaire (SDQ), and Sleep Disturbance Scale for Children (SDSC) substance abuse, Level of Puberty (Tanner scale), Food frequency questionnaire (FFQ)
- ActiGraph (acceleration sensor), assessment of physical activity and sleep for 7 days
- Blood samples for analyses of: glucose and insulin metabolism, vitamin D, Calcium, Phosphate, AFOS and PTH, blood samples for assessment of lipidomics and metabonomics, DNA-sample (blood and buccal) and samples for adipocytokines and inflammation marker assessment
- Endothelial function and pulse wave velocity (PWV) will be assessed
- An epigenome-wide association study (EWAS) will be performed in the offspring according to maternal obesity and GDM status.
- Continuous glucose monitoring (CGM, Dexcom G6, Dexcom®, USA) will be assessed in a subpopulation of 150 children, aged 11-14 yrs: 50 overweight/obese and 50 normal weight children from high-risk pregnancies (RADIEL) and 50 normal weight controls form normal pregnancies (PREDO).
The following maternal data will be collected 11-17 years post partum (data entry and quality control 1/22-6/24):
- Blood pressure, pulse, weight, height, BMI, waist and hip circumference
- Body fat percentage (bioimpedance, InBody).
- Laboratory tests: OGTT, insulin, glucose, HbA1c, ALAT, lipids, TSH, free T4, DNA sample (blood)
- DNA sample from buccal mucosa
- Spare blood for future analyses (metabonomics and lipidonomics studies, inflammatory markers incl, P-hCRP, P-IL-6, adiponectin, TNFa)
- Digital questionnaires: background, diet (FFQ) and physical activity, psychological questionnaires: Center of Epidemiological Studies Depression Scale (CES-D), Beck Anxiety Inventory II (BDI-II), Pittsburgh Sleep Quality Index (PSQI), Cohen Perceived Stress Scale (PSS5), PANAS-10 (Positive and negative affect schedule), VAS Social Support (Visual Analogue Scale for Social Support), and STAI state (Spielberger State-Trait-Anxiety-Inventory-state version
- food frequency questionnaire (FFQ)
- ActiGraph (acceleration sensor), assessment of physical activity and sleep for 7 days
- Endothelial function and pulse wave velocity (PWV)
National registries and patient records on the course of pregnancy, the growth and development of the child and related diseases or their risk factors

연구 유형

관찰

등록 (추정된)

750

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Saila B Koivusalo, prof
전화번호: +358407250620
이메일: saila.koivusalo@hus.fi

연구 장소

핀란드
- - Helsinki, 핀란드, 00290
    - 모병
    - Saila Koivusalo
    - 연락하다:
      
      Saila B Koivusalo, prof
      
      전화번호: +358407250620
      
      이메일: saila.koivusalo@hus.fi
    - 연락하다:
      
      Katri Räikkönen, prof
      
      이메일: katri.raikkonen@helsinki.fi

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

11년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

The study population comprises two Finnish pregnancy cohort /prevention studies, in which mother-child pairs have already been followed from early pregnancy until the threshold of adolescence.

Women for the PREDO study were enrolled at 12-14 gestational weeks and for the RADIEL study before conception or at 10-12 gestational weeks. They gave birth to a singleton live infant between 2006-2010 (PREDO) and 2008-2014 (RADIEL).

설명

Inclusion Criteria:

all mothers participated originally in the PREDO or the RADIEL studies during pregnancy and with delivery during this index pregnancy

Exclusion Criteria:

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

관찰 모델: COHORT
시간 관점: PROSPECTIVE

그룹/코호트 수

코호트 및 개입

그룹/코호트
Prevention of Pre-eclampsia and Intrauterine Growth Restriction (PREDO) The PREDO study is a cohort study that was started in 2005 in the Helsinki metropolitan area and Northern Karelia. In 2005-2009, it recruited a total of 4,777 women in the early pregnancy. Almost all subjects participated in stress monitoring during pregnancy. In addition, some mothers participated in either genetic, ultrasound, or drug research to develop methods for predicting and preventing pre-eclampsia and fetal growth retardation, and for identifying related factors. Some key objectives have been to determine whether the physical and mental well-being of the pregnant women could be relevant with hereditary factors for the course of pregnancy and the subsequent physical and mental development and health of the child. The previous follow-up phases have been performed 2 weeks and 6 months after the birth in 2006-2011 and at the age of approximately 2-6 and 7-12 years. More than 2,500 families participated in the most recent follow-up phase. Now it is 11-17 years of follow-up.
Finnish Gestational Diabetes Prevention (RADIEL) The RADIEL study is a randomized multicenter study that was launched in 2008 in Helsinki, Espoo, Vantaa and Lappeenranta. Between 2008 and 2011, we recruited a total of 729 women for gestational diabetes prevention research. Subjects either planned to become pregnant or were in early pregnancy at the time of the study. Subjects were randomized to either receive diet and exercise intervention (active group) or to continue with normal counseling follow-up (control group). Study visits occurred every three months before pregnancy (if recruited before pregnancy), once in each trimester of pregnancy, and at 6 weeks, 6 months, and 12 months after delivery. The effectiveness of the intervention was measured with a variety of metrics. In 2013-2017, we invited mothers and children who participated in the RADIEL study to a 5-year follow-up of the project, and nearly 350 mother-child pairs participated. Now it is 11-17 years of follow-up.

그룹/코호트

Prevention of Pre-eclampsia and Intrauterine Growth Restriction (PREDO)

The PREDO study is a cohort study that was started in 2005 in the Helsinki metropolitan area and Northern Karelia. In 2005-2009, it recruited a total of 4,777 women in the early pregnancy. Almost all subjects participated in stress monitoring during pregnancy. In addition, some mothers participated in either genetic, ultrasound, or drug research to develop methods for predicting and preventing pre-eclampsia and fetal growth retardation, and for identifying related factors.

Some key objectives have been to determine whether the physical and mental well-being of the pregnant women could be relevant with hereditary factors for the course of pregnancy and the subsequent physical and mental development and health of the child.

The previous follow-up phases have been performed 2 weeks and 6 months after the birth in 2006-2011 and at the age of approximately 2-6 and 7-12 years. More than 2,500 families participated in the most recent follow-up phase. Now it is 11-17 years of follow-up.

Finnish Gestational Diabetes Prevention (RADIEL)

The RADIEL study is a randomized multicenter study that was launched in 2008 in Helsinki, Espoo, Vantaa and Lappeenranta. Between 2008 and 2011, we recruited a total of 729 women for gestational diabetes prevention research. Subjects either planned to become pregnant or were in early pregnancy at the time of the study. Subjects were randomized to either receive diet and exercise intervention (active group) or to continue with normal counseling follow-up (control group). Study visits occurred every three months before pregnancy (if recruited before pregnancy), once in each trimester of pregnancy, and at 6 weeks, 6 months, and 12 months after delivery. The effectiveness of the intervention was measured with a variety of metrics.

In 2013-2017, we invited mothers and children who participated in the RADIEL study to a 5-year follow-up of the project, and nearly 350 mother-child pairs participated. Now it is 11-17 years of follow-up.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Body fat percentage 기간: one measure at follow-up study visit:11-17 years after pregnancy	Measured by Inbody 720 (bioimpedance)	one measure at follow-up study visit:11-17 years after pregnancy

2차 결과 측정

결과 측정	측정값 설명	기간
Blood pressure 기간: 2-3 measurements at follow-up study visit: 11-17 years after pregnancy	Both systolic and diastolic pressures are measured by Omron HBP-1320	2-3 measurements at follow-up study visit: 11-17 years after pregnancy
Body mass index 기간: one measure at follow-up study visit: 11-17 years after pregnancy	weight (kg) / height (m)2	one measure at follow-up study visit: 11-17 years after pregnancy
Pulse wave velocity 기간: one measure at follow-up study visit: 11-17 years after pregnancy	Measured by Complior Analyse, Alarm Medical	one measure at follow-up study visit: 11-17 years after pregnancy
Time in target he percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l) 기간: 10 days measurements related to the 11-17 years follow-up study visit	Dexcom G6 CGM (continuous glucose monitoring)	10 days measurements related to the 11-17 years follow-up study visit
Body weight 기간: one measurement at follow-up study visit: 11-17 years after pregnancy	Measured with Seca Mod 878DR (scale)	one measurement at follow-up study visit: 11-17 years after pregnancy

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Helsinki University Central Hospital

협력자

University of Edinburgh

University of Helsinki

University of Oulu

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2022년 2월 25일

기본 완료 (추정된)

2026년 12월 31일

연구 완료 (추정된)

2026년 12월 31일

연구 등록 날짜

최초 제출

2022년 1월 18일

QC 기준을 충족하는 최초 제출

2022년 2월 3일

처음 게시됨 (실제)

2022년 2월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 23일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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