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

Endothelial Dysfunction Clinical Trial

— EFFECTOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02992106
• Other study ID #: EFFECTOR
• Status: Completed
• Phase: N/A
• Start date: May 10, 2017
• Est. completion date: March 18, 2019

Study information

• Verified date: August 2019
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: March 18, 2019
• Est. primary completion date: March 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Obesity
• Endothelial Dysfunction
• Obesity
• Pediatric Obesity

Intervention

Other:
• Parental questionnaires
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
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-a and ICAM-1.
• Urine sample
We will take a urine sample to evaluate the albumin to creatinin ratio.
• Anthropometric measurements
We will measure weight, Height, hip, waist and neck circumference, blood pressure, 4-site skinfold measurements and BIA.
• Ultrasound
We will do an abdominal ultrasound to measure the abdominal fat accumulation
• EndoPAT
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
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

Locations

Country	Name	City	State
Belgium	University Hospital of Brussels	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel	Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reactive Hyperemia Index (EndoPAT)	Reactive Hyperemia Index is one of the outcome parameters of the EndoPAT assessment of endothelial cell function	Through study completion, average of 18 months
Primary	Albumin to creatinin ratio in urine	Albumin to creatinin ratio is considered an early marker of endothelial cell dysfunction	Through study completion, average of 18 months
Primary	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	Through study completion, average of 18 months
Secondary	BMI (kg/m²)	The BMI is considered one of the parameters regarding obtaining information on the body composition of children	Through study completion, average of 18 months
Secondary	Body fat percentage	To assess body fat percentage the results of the BIA, abdominal ultrasound and skinfold measurements will be taken into account	Through study completion, average of 18 months
Secondary	Insulin resistance	The assessment of insulin resistance will be made possible through the analysis of the blood sample (glucose and insulin level are measured)	Through study completion, average of 18 months
Secondary	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	Through study completion, average of 18 months
Secondary	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	Through study completion, average of 18 months