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

Primary Purpose

Endothelial Dysfunction, Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Parental questionnaires
Blood sample
Urine sample
Anthropometric measurements
Ultrasound
EndoPAT
Faces Pain Scale
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Endothelial Dysfunction focused on measuring Maternal Obesity, Endothelial Dysfunction, Childhood Obesity

Eligibility Criteria

6 Months - 11 Years (Child)All SexesAccepts 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.

Sites / Locations

  • University Hospital of Brussels

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Normal weight during pregnancy

Obese mothers without intervention

Obese mothers & lifestyle intervention

History of bariatric surgery

Arm 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

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

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

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

Outcomes

Primary Outcome Measures

Reactive Hyperemia Index (EndoPAT)
Reactive Hyperemia Index is one of the outcome parameters of the EndoPAT assessment of endothelial cell function
Albumin to creatinin ratio in urine
Albumin to creatinin ratio is considered an early marker of endothelial cell dysfunction
Peak response after occlusion (EndoPAT)
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

Secondary Outcome Measures

BMI (kg/m²)
The BMI is considered one of the parameters regarding obtaining information on the body composition of children
Body fat percentage
To assess body fat percentage the results of the BIA, abdominal ultrasound and skinfold measurements will be taken into account
Insulin resistance
The assessment of insulin resistance will be made possible through the analysis of the blood sample (glucose and insulin level are measured)
Inflammatory state of the child (hs-CRP and IL-6)
The assessment of inflammatory state will be an assessment of the hs-CRP and IL-6 levels taken into account
Lipid state in blood
The assessment of lipid state will be an assessment of the total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerids taken into account

Full Information

First Posted
December 5, 2016
Last Updated
August 6, 2019
Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT02992106
Brief Title
Evolution of Maternal Weight During Pregnancy and Influence on the Endothelial Function in Her Offspring
Acronym
EFFECTOR
Official Title
Evolution of Maternal Weight During Pregnancy and Influence on the Endothelial Function in Her Offspring
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
March 18, 2019 (Actual)
Study Completion Date
March 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Dysfunction, Childhood Obesity
Keywords
Maternal Obesity, Endothelial Dysfunction, Childhood Obesity

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal weight during pregnancy
Arm Type
Other
Arm 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
Arm Title
Obese mothers without intervention
Arm Type
Other
Arm 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
Arm Title
Obese mothers & lifestyle intervention
Arm Type
Other
Arm 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
Arm Title
History of bariatric surgery
Arm Type
Other
Arm 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
Intervention Type
Other
Intervention Name(s)
Parental questionnaires
Intervention Description
We will provide parents with questionnaires depending on the age of their children: Children aged 0-6 years old: Questionnaire on socio-demographic characteristics Dutch Eating Behaviour Questionnaire Food Frequency Questionnaire Ages and Stages Questionnaire Strengths and Difficulties Questionnaire Questionnaire on developmental milestones Questionnaire on behaviour Children older than 6 years: Questionnaire on socio-demographic characteristics Dutch Eating Behaviour Questionnaire Food Frequency Questionnaire Pediatric Quality of Life Questionnaire Children's Behaviour Questionnaire in Dutch Questionnaire on developmental milestones Developmental Coordination Disorder Questionnaire Strengths and Difficulties Questionnaire
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Urine sample
Intervention Description
We will take a urine sample to evaluate the albumin to creatinin ratio.
Intervention Type
Other
Intervention Name(s)
Anthropometric measurements
Intervention Description
We will measure weight, Height, hip, waist and neck circumference, blood pressure, 4-site skinfold measurements and BIA.
Intervention Type
Other
Intervention Name(s)
Ultrasound
Intervention Description
We will do an abdominal ultrasound to measure the abdominal fat accumulation
Intervention Type
Other
Intervention Name(s)
EndoPAT
Intervention Description
We will use the EndoPAT device to measure endothelial function, which is a non-invasive and innovative technique (peripheral pulse wave amplitude measurement).
Intervention Type
Other
Intervention Name(s)
Faces Pain Scale
Intervention Description
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
Primary Outcome Measure Information:
Title
Reactive Hyperemia Index (EndoPAT)
Description
Reactive Hyperemia Index is one of the outcome parameters of the EndoPAT assessment of endothelial cell function
Time Frame
Through study completion, average of 18 months
Title
Albumin to creatinin ratio in urine
Description
Albumin to creatinin ratio is considered an early marker of endothelial cell dysfunction
Time Frame
Through study completion, average of 18 months
Title
Peak response after occlusion (EndoPAT)
Description
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
Time Frame
Through study completion, average of 18 months
Secondary Outcome Measure Information:
Title
BMI (kg/m²)
Description
The BMI is considered one of the parameters regarding obtaining information on the body composition of children
Time Frame
Through study completion, average of 18 months
Title
Body fat percentage
Description
To assess body fat percentage the results of the BIA, abdominal ultrasound and skinfold measurements will be taken into account
Time Frame
Through study completion, average of 18 months
Title
Insulin resistance
Description
The assessment of insulin resistance will be made possible through the analysis of the blood sample (glucose and insulin level are measured)
Time Frame
Through study completion, average of 18 months
Title
Inflammatory state of the child (hs-CRP and IL-6)
Description
The assessment of inflammatory state will be an assessment of the hs-CRP and IL-6 levels taken into account
Time Frame
Through study completion, average of 18 months
Title
Lipid state in blood
Description
The assessment of lipid state will be an assessment of the total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerids taken into account
Time Frame
Through study completion, average of 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Devlieger, Professor
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Inge Gies, Professor
Organizational Affiliation
University Hospital of Brussels
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karolien Van De Maele, M.D.
Organizational Affiliation
University Hospital of Brussels
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Brussels
City
Brussels
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30815589
Citation
Van De Maele K, Gies I, Devlieger R. Effect of bariatric surgery before pregnancy on the vascular function in the offspring: protocol of a cross-sectional follow-up study. BMJ Paediatr Open. 2019 Jan 31;3(1):e000405. doi: 10.1136/bmjpo-2018-000405. eCollection 2019.
Results Reference
derived

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

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