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Completed

NCT Number: NCT02992106

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

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.

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Key information

Conditions

Endothelial Dysfunction Body Weight Childhood Obesity Female Urogenital Diseases and Pregnancy Complications Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Pregnancy Complications Pregnancy in Obesity Signs and Symptoms Urogenital Diseases

Age range

6 month–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Brussels

Brussels, 1090, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parental questionnaires

Other

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

blood sample

Other

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 sample

Other

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

Anthropometric measurements

Other

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

ultrasound

Other

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

EndoPAT

Other

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 Scale

Other

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 outcomes

  1. Reactive Hyperemia Index (EndoPAT)

    Time frame: Through study completion, average of 18 months

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

  2. Albumin to creatinin ratio in urine

    Time frame: Through study completion, average of 18 months

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

  3. Peak response after occlusion (EndoPAT)

    Time frame: 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

Secondary outcomes

  1. BMI (kg/m²)

    Time frame: Through study completion, average of 18 months

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

  2. Body fat percentage

    Time frame: 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

  3. Insulin resistance

    Time frame: 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)

  4. Inflammatory state of the child (hs-CRP and IL-6)

    Time frame: 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

  5. Lipid state in blood

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Collaborators

  • Universitaire Ziekenhuizen KU Leuven

Registry information

Acronym: EFFECTOR

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2016
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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