Evolution of Maternal Weight During Pregnancy and Influence on the Endothelial Function in Her Offspring (EFFECTOR)

Universitair Ziekenhuis Brussel

Status: Completed

Conditions: Endothelial Dysfunction; Childhood Obesity

Treatments: Other: Ultrasound; Other: Faces Pain Scale; Other: Urine sample; Other: Parental questionnaires; Other: EndoPAT; Other: Anthropometric measurements; Other: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT02992106

EFFECTOR

Details and patient eligibility

About

The rising worldwide prevalence of obesity and its subsequently rising incidence of concommitant diseases as diabetes and cardiovascular events impose a defiant obstacle for the health care and associated health care costs of future generations. Obese pregnant women are a growing population of interest because their offspring is at risk for childhood obesity, an adverse metabolic and inflammatory profile and possible endothelial dysfunction. However, strong evidence is still lacking regarding the hypotheses on the early origin of these long-term health consequences.

Consequently there is no comprehensive data available on the contribution of changing maternal weight through lifestyle interventions or bariatric surgery and an eventual adverse metabolic and endothelial programming of the offspring.

The investigators of this study want to provide additional data on the body composition, metabolic and inflammatory state as well as endothelial function of children of obese pregnant women women and compare the outcome with children born from normal weight women. Furthermore, the investigators of this study will stratify the obese pregnant women into 3 groups: women who did not underwent an intervention, women who underwent a weight changing intervention during pregnancy e.g. diet or lifestyle intervention and women who underwent bariatric surgery before pregnancy. The overall aim of the study is to prove that in all the diverse groups of participating children, except the control group, there will be a certain grade of endothelial dysfunction, even if there was a normalization of weight, insulin sensitivity and inflammation before conception or delivery in the mother.

Enrollment: 143 patients

Sex: All

Ages: 6 months to 11 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children of women who previously participated in different cohort studies conducted in Flanders concerning maternal obesity are included after contacting the mothers again. During the initial clinical trials the mothers were informed of possible follow-up studies on their offspring.

Exclusion criteria

• There are no absolute exclusion criteria formulated.
• For the peripheral pulse wave amplitude measurement we exclude children on growth hormone therapy.
• We postpone the examination for 2 weeks if there is an ongoing infection.
• We document the use of specific medication, but the use of it doesn't implicate exclusion of the participating children.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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143 participants in 4 patient groups

Normal weight during pregnancy

Other group

Description:

Offspring of 156 women with a normal weight during their pregnancy recruited by Bogaerts et al, in 3 belgian hospitals. Results of maternal data published in 2013. Now the children will be recruited. This group wil function as a control group. All participating children will undergo the same examinations: * Parental questionnaires * Blood sample * Urine sample * Anthropometric measurements * Abdominal ultrasound (fat mass) * EndoPAT

Treatment:

Other: EndoPAT

Other: Urine sample

Other: Anthropometric measurements

Other: Parental questionnaires

Other: Faces Pain Scale

Other: Blood sample

Other: Ultrasound

Obese mothers without intervention

Other group

Description:

This subgroup will be compiled of the offspring of women recruited in two different studies. First of all there is the offspring of 65 women from the cohort that was recruited by Guelinckx et al, data published in 2010. This population was recruited in the University hospital of Leuven as control group for women receiving lifestyle interventions during pregnancy. Secondly there are children of 63 women from the cohort of Bogaerts et al of 2013 that had a BMI \> 29 kg/m² during their singleton pregnancy. All participating children will undergo the same examinations: * Parental questionnaires * Blood sample * Urine sample * Anthropometric measurements * Abdominal ultrasound (fat mass) * EndoPAT

Treatment:

Other: EndoPAT

Other: Urine sample

Other: Anthropometric measurements

Other: Parental questionnaires

Other: Faces Pain Scale

Other: Blood sample

Other: Ultrasound

Obese mothers & lifestyle intervention

Other group

Description:

This one will also be a composition of study subjects of two different study cohorts. Firstly there are children of about 100 Belgian women that were included in the DALI cohort, a European randomized controlled trial. All of them underwent a lifestyle intervention during pregnancy, concerning diet and/ or exercise. Secondly there is the offspring of the other subgroup of the cohort recruited by Guelinckx et al. 130 women were divided into 2 groups which underwent lifestyle interventions during pregnancy. All participating children will undergo the same examinations: * Parental questionnaires * Blood sample * Urine sample * Anthropometric measurements * Abdominal ultrasound (fat mass) * EndoPAT

Treatment:

Other: EndoPAT

Other: Urine sample

Other: Anthropometric measurements

Other: Parental questionnaires

Other: Faces Pain Scale

Other: Blood sample

Other: Ultrasound

History of bariatric surgery

Other group

Description:

The PABAS cohort (Pregnancy After Bariatric Surgery) provides children of 49 women who underwent bariatric surgery before their singleton pregnancy. The women were included in five Flemish hospitals before 15 weeks of pregnancy. Furthermore we will recruit the offspring of 200 women that are recruited in the ongoing AURORA cohort (bAriatric sUrgery Registration in women Of Reproductive Age). Women in this cohort are recruited from the start of their process undergoing bariatric surgery and are followed until after their pregnancy. All participating children will undergo the same examinations: * Parental questionnaires * Blood sample * Urine sample * Anthropometric measurements * Abdominal ultrasound (fat mass) * EndoPAT

Treatment:

Other: EndoPAT

Other: Urine sample

Other: Anthropometric measurements

Other: Parental questionnaires

Other: Faces Pain Scale

Other: Blood sample

Other: Ultrasound