Evolution of Maternal Weight During Pregnancy and Influence on the Endothelial Function in Her Offspring
Not Applicable
Completed
- Conditions
- Childhood ObesityEndothelial Dysfunction
- Interventions
- Other: Parental questionnairesOther: Blood sampleOther: Urine sampleOther: Anthropometric measurementsOther: UltrasoundOther: EndoPATOther: Faces Pain Scale
- Registration Number
- NCT02992106
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 143
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal weight during pregnancy EndoPAT 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 Normal weight during pregnancy Faces Pain Scale 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 Normal weight during pregnancy Blood sample 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 Normal weight during pregnancy Ultrasound 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 Obese mothers without intervention Ultrasound 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 Obese mothers without intervention Faces Pain Scale 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 Obese mothers & lifestyle intervention Urine sample 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 Normal weight during pregnancy Parental questionnaires 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 Normal weight during pregnancy Anthropometric measurements 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 Obese mothers without intervention Parental questionnaires 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 Normal weight during pregnancy Urine sample 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 Obese mothers without intervention Blood sample 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 Obese mothers without intervention Anthropometric measurements 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 Obese mothers & lifestyle intervention Blood sample 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 Obese mothers & lifestyle intervention Anthropometric measurements 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 History of bariatric surgery Parental questionnaires 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 Obese mothers without intervention Urine sample 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 Obese mothers & lifestyle intervention Parental questionnaires 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 Obese mothers & lifestyle intervention Ultrasound 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 History of bariatric surgery Urine sample 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 Obese mothers without intervention EndoPAT 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 Obese mothers & lifestyle intervention EndoPAT 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 Obese mothers & lifestyle intervention Faces Pain Scale 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 History of bariatric surgery Anthropometric measurements 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 History of bariatric surgery EndoPAT 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 History of bariatric surgery Blood sample 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 History of bariatric surgery Ultrasound 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 History of bariatric surgery Faces Pain Scale 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
- Primary Outcome Measures
Name Time Method Reactive Hyperemia Index (EndoPAT) Through study completion, average of 18 months Reactive Hyperemia Index is one of the outcome parameters of the EndoPAT assessment of endothelial cell function
Peak response after occlusion (EndoPAT) Through study completion, average of 18 months Determination of the peak response using 30s average of amplitude intervals./ In children considered as an important measurement regarding assessment of the endothelial cell function
Albumin to creatinin ratio in urine Through study completion, average of 18 months Albumin to creatinin ratio is considered an early marker of endothelial cell dysfunction
- Secondary Outcome Measures
Name Time Method Insulin resistance Through study completion, average of 18 months The assessment of insulin resistance will be made possible through the analysis of the blood sample (glucose and insulin level are measured)
Lipid state in blood Through study completion, average of 18 months The assessment of lipid state will be an assessment of the total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerids taken into account
Body fat percentage Through study completion, average of 18 months To assess body fat percentage the results of the BIA, abdominal ultrasound and skinfold measurements will be taken into account
BMI (kg/m²) Through study completion, average of 18 months The BMI is considered one of the parameters regarding obtaining information on the body composition of children
Inflammatory state of the child (hs-CRP and IL-6) Through study completion, average of 18 months The assessment of inflammatory state will be an assessment of the hs-CRP and IL-6 levels taken into account
Trial Locations
- Locations (1)
University Hospital of Brussels
🇧🇪Brussels, Belgium