Evolution of Maternal Weight During Pregnancy and Influence on the Endothelial Function in Her Offspring (EFFECTOR)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Brussels, Belgium, 1090
- University Hospital of Brussels
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Normal weight during pregnancy
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:
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We will provide parents with questionnaires depending on the age of their children:
We will determine the following biochemical parameters: glucose, insulin, total cholesterol, LDL, HDL, triglycerides, uric acid, IGF-1, adiponectin, leptin, hs-CRP, IL-6, TNF-α and ICAM-1.
We will take a urine sample to evaluate the albumin to creatinin ratio.
We will measure weight, Height, hip, waist and neck circumference, blood pressure, 4-site skinfold measurements and BIA.
We will do an abdominal ultrasound to measure the abdominal fat accumulation
We will use the EndoPAT device to measure endothelial function, which is a non-invasive and innovative technique (peripheral pulse wave amplitude measurement).
After performing the measurements with the EndoPAT device, Harpender kalliper and ultrasound, the children will be asked to fill out a Faces Pain Scale, validated for children aged 4-16 years old and obtained for use from the International Association for the Study of Pain
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Other: Obese mothers without intervention
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:
|
We will provide parents with questionnaires depending on the age of their children:
We will determine the following biochemical parameters: glucose, insulin, total cholesterol, LDL, HDL, triglycerides, uric acid, IGF-1, adiponectin, leptin, hs-CRP, IL-6, TNF-α and ICAM-1.
We will take a urine sample to evaluate the albumin to creatinin ratio.
We will measure weight, Height, hip, waist and neck circumference, blood pressure, 4-site skinfold measurements and BIA.
We will do an abdominal ultrasound to measure the abdominal fat accumulation
We will use the EndoPAT device to measure endothelial function, which is a non-invasive and innovative technique (peripheral pulse wave amplitude measurement).
After performing the measurements with the EndoPAT device, Harpender kalliper and ultrasound, the children will be asked to fill out a Faces Pain Scale, validated for children aged 4-16 years old and obtained for use from the International Association for the Study of Pain
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Other: Obese mothers & lifestyle intervention
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:
|
We will provide parents with questionnaires depending on the age of their children:
We will determine the following biochemical parameters: glucose, insulin, total cholesterol, LDL, HDL, triglycerides, uric acid, IGF-1, adiponectin, leptin, hs-CRP, IL-6, TNF-α and ICAM-1.
We will take a urine sample to evaluate the albumin to creatinin ratio.
We will measure weight, Height, hip, waist and neck circumference, blood pressure, 4-site skinfold measurements and BIA.
We will do an abdominal ultrasound to measure the abdominal fat accumulation
We will use the EndoPAT device to measure endothelial function, which is a non-invasive and innovative technique (peripheral pulse wave amplitude measurement).
After performing the measurements with the EndoPAT device, Harpender kalliper and ultrasound, the children will be asked to fill out a Faces Pain Scale, validated for children aged 4-16 years old and obtained for use from the International Association for the Study of Pain
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Other: History of bariatric surgery
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:
|
We will provide parents with questionnaires depending on the age of their children:
We will determine the following biochemical parameters: glucose, insulin, total cholesterol, LDL, HDL, triglycerides, uric acid, IGF-1, adiponectin, leptin, hs-CRP, IL-6, TNF-α and ICAM-1.
We will take a urine sample to evaluate the albumin to creatinin ratio.
We will measure weight, Height, hip, waist and neck circumference, blood pressure, 4-site skinfold measurements and BIA.
We will do an abdominal ultrasound to measure the abdominal fat accumulation
We will use the EndoPAT device to measure endothelial function, which is a non-invasive and innovative technique (peripheral pulse wave amplitude measurement).
After performing the measurements with the EndoPAT device, Harpender kalliper and ultrasound, the children will be asked to fill out a Faces Pain Scale, validated for children aged 4-16 years old and obtained for use from the International Association for the Study of Pain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reactive Hyperemia Index (EndoPAT)
Time Frame: Through study completion, average of 18 months
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Reactive Hyperemia Index is one of the outcome parameters of the EndoPAT assessment of endothelial cell function
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Through study completion, average of 18 months
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Albumin to creatinin ratio in urine
Time Frame: Through study completion, average of 18 months
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Albumin to creatinin ratio is considered an early marker of endothelial cell dysfunction
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Through study completion, average of 18 months
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Peak response after occlusion (EndoPAT)
Time Frame: Through study completion, average of 18 months
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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
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Through study completion, average of 18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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BMI (kg/m²)
Time Frame: Through study completion, average of 18 months
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The BMI is considered one of the parameters regarding obtaining information on the body composition of children
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Through study completion, average of 18 months
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Body fat percentage
Time Frame: Through study completion, average of 18 months
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To assess body fat percentage the results of the BIA, abdominal ultrasound and skinfold measurements will be taken into account
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Through study completion, average of 18 months
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Insulin resistance
Time Frame: Through study completion, average of 18 months
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The assessment of insulin resistance will be made possible through the analysis of the blood sample (glucose and insulin level are measured)
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Through study completion, average of 18 months
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Inflammatory state of the child (hs-CRP and IL-6)
Time Frame: Through study completion, average of 18 months
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The assessment of inflammatory state will be an assessment of the hs-CRP and IL-6 levels taken into account
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Through study completion, average of 18 months
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Lipid state in blood
Time Frame: Through study completion, average of 18 months
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The assessment of lipid state will be an assessment of the total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerids taken into account
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Through study completion, average of 18 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Roland Devlieger, Professor, Universitaire Ziekenhuizen KU Leuven
- Principal Investigator: Inge Gies, Professor, University Hospital of Brussels
- Study Director: Karolien Van De Maele, M.D., University Hospital of Brussels
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFFECTOR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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