Evolution of Maternal Weight During Pregnancy and Influence on the Endothelial Function in Her Offspring
- Conditions
- Childhood ObesityEndothelial Dysfunction
- Registration Number
- NCT02992106
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 143
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
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
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
- Secondary Outcome Measures
Name Time Method 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)
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
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
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
Trial Locations
- Locations (1)
University Hospital of Brussels
🇧🇪Brussels, Belgium
University Hospital of Brussels🇧🇪Brussels, Belgium