Endothelial Dysfunction, Childhood Obesity
Conditions
Keywords
Maternal Obesity, Endothelial Dysfunction, Childhood Obesity
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.
Interventions
We will measure weight, Height, hip, waist and neck circumference, blood pressure, 4-site skinfold measurements and BIA.
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
OTHERBlood 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.
OTHERUrine sample
We will take a urine sample to evaluate the albumin to creatinin ratio.
OTHERUltrasound
We will do an abdominal ultrasound to measure the abdominal fat accumulation
OTHEREndoPAT
We will use the EndoPAT device to measure endothelial function, which is a non-invasive and innovative technique (peripheral pulse wave amplitude measurement).
OTHERFaces 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
Sponsors
Universitaire Ziekenhuizen KU Leuven
Universitair Ziekenhuis Brussel
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 11 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reactive Hyperemia Index (EndoPAT) | Through study completion, average of 18 months | Reactive Hyperemia Index is one of the outcome parameters of the EndoPAT assessment of endothelial cell function |
| Albumin to creatinin ratio in urine | Through study completion, average of 18 months | Albumin to creatinin ratio is considered an early marker of endothelial cell dysfunction |
| Peak response after occlusion (EndoPAT) | 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
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory state of the child (hs-CRP and IL-6) | 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 |
| BMI (kg/m²) | Through study completion, average of 18 months | The BMI is considered one of the parameters regarding obtaining information on the body composition of children |
| Lipid state in blood | 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 |
| Body fat percentage | 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 |
| Insulin resistance | 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) |
Countries
Belgium
Outcome results
None listed