NCT02992106

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 6 Months – 11 Years
• Healthy volunteers: Accepted

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.

Conditions

• Endothelial Dysfunction
• Childhood Obesity

Interventions

Type	Name	Description
OTHER	Parental questionnaires	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
OTHER	Blood sample	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.
OTHER	Urine sample	We will take a urine sample to evaluate the albumin to creatinin ratio.
OTHER	Anthropometric measurements	We will measure weight, Height, hip, waist and neck circumference, blood pressure, 4-site skinfold measurements and BIA.
OTHER	Ultrasound	We will do an abdominal ultrasound to measure the abdominal fat accumulation
OTHER	EndoPAT	We will use the EndoPAT device to measure endothelial function, which is a non-invasive and innovative technique (peripheral pulse wave amplitude measurement).
OTHER	Faces Pain Scale	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

Timeline

• Start date: 2017-05-10
• Primary completion: 2019-03-18
• Completion: 2019-03-18
• First posted: 2016-12-14
• Last updated: 2019-08-07

Locations

1 site across 1 country: Belgium