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Endothelial DysfunctionEFFECTORNCT02992106

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

A study testing Parental questionnaires, Blood sample and Urine sample in people with Endothelial Dysfunction and Childhood Obesity, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 months to 11 yearsHealthy volunteers can take part
Conditions the study is for
Endothelial Dysfunction, Childhood Obesity
What is being tested?
Parental questionnaires, Blood sample and Urine sample
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
1 siteBelgium
Study dates
10 May 2017to 18 Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Belgium1 site

  • University Hospital of Brussels

    Brussels, 1090

Other trials in Belgium

About this study

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.

Being tested
Parental questionnaires, Blood sample, Urine sample, Anthropometric measurements, Ultrasound
Keywords
Maternal Obesity, Endothelial Dysfunction, Childhood Obesity
Medical subject headings
Pediatric Obesity, Pregnancy in Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parental questionnairesOther

    We will provide parents with questionnaires depending on the age of their children:

    • Children aged 0-6 years old:
    1. Questionnaire on socio-demographic characteristics
    2. Dutch Eating Behaviour Questionnaire
    3. Food Frequency Questionnaire
    4. Ages and Stages Questionnaire
    5. Strengths and Difficulties Questionnaire
    6. Questionnaire on developmental milestones
    7. Questionnaire on behaviour
    • Children older than 6 years:
    1. Questionnaire on socio-demographic characteristics
    2. Dutch Eating Behaviour Questionnaire
    3. Food Frequency Questionnaire
    4. Pediatric Quality of Life Questionnaire
    5. Children's Behaviour Questionnaire in Dutch
    6. Questionnaire on developmental milestones
    7. Developmental Coordination Disorder Questionnaire
    8. Strengths and Difficulties Questionnaire

  • Blood sampleOther

    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.

  • Urine sampleOther

    We will take a urine sample to evaluate the albumin to creatinin ratio.

  • Anthropometric measurementsOther

    We will measure weight, Height, hip, waist and neck circumference, blood pressure, 4-site skinfold measurements and BIA.

  • UltrasoundOther

    We will do an abdominal ultrasound to measure the abdominal fat accumulation

  • EndoPATOther

    We will use the EndoPAT device to measure endothelial function, which is a non-invasive and innovative technique (peripheral pulse wave amplitude measurement).

  • Faces Pain ScaleOther

    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

Study groups in NCT02992106
Study groupRoleWhat they receive
Normal weight during pregnancyOtherOffspring 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
Receives: Other: Parental questionnaires; Other: Blood sample; Other: Urine sample; Other: Anthropometric measurements; Other: Ultrasound; Other: EndoPAT; Other: Faces Pain Scale
Obese mothers without interventionOtherThis 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
Receives: Other: Parental questionnaires; Other: Blood sample; Other: Urine sample; Other: Anthropometric measurements; Other: Ultrasound; Other: EndoPAT; Other: Faces Pain Scale
Obese mothers & lifestyle interventionOtherThis 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
Receives: Other: Parental questionnaires; Other: Blood sample; Other: Urine sample; Other: Anthropometric measurements; Other: Ultrasound; Other: EndoPAT; Other: Faces Pain Scale
History of bariatric surgeryOtherThe 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
Receives: Other: Parental questionnaires; Other: Blood sample; Other: Urine sample; Other: Anthropometric measurements; Other: Ultrasound; Other: EndoPAT; Other: Faces Pain Scale

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reactive Hyperemia Index (EndoPAT)

    Reactive Hyperemia Index is one of the outcome parameters of the EndoPAT assessment of endothelial cell function

    Measured: Through study completion, average of 18 months

  2. Albumin to creatinin ratio in urine

    Albumin to creatinin ratio is considered an early marker of endothelial cell dysfunction

    Measured: Through study completion, average of 18 months

  3. 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

    Measured: Through study completion, average of 18 months

Secondary outcomes (5)

  1. BMI (kg/m²)

    The BMI is considered one of the parameters regarding obtaining information on the body composition of children

    Measured: Through study completion, average of 18 months

  2. Body fat percentage

    To assess body fat percentage the results of the BIA, abdominal ultrasound and skinfold measurements will be taken into account

    Measured: Through study completion, average of 18 months

  3. Insulin resistance

    The assessment of insulin resistance will be made possible through the analysis of the blood sample (glucose and insulin level are measured)

    Measured: Through study completion, average of 18 months

  4. 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

    Measured: Through study completion, average of 18 months

  5. 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

    Measured: Through study completion, average of 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2016 (estimated)
  2. Study start10 May 2017
  3. Primary completion18 Mar 2019
  4. Study completion18 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02992106
Sponsor's protocol ID
EFFECTOR
Acronym
EFFECTOR
Status last verified
Aug 2019
First submitted
5 Dec 2016
Last updated
7 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30815589

Questions about this trial

What is this clinical trial studying?

A study testing Parental questionnaires, Blood sample and Urine sample in people with Endothelial Dysfunction and Childhood Obesity, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reactive Hyperemia Index (EndoPAT) (time frame: Through study completion, average of 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02992106, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.

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