Clinical trial NCT02992106: Evolution of Maternal Weight During Pregnancy and Influence on the Endothelial Function in Her Offspring
Official title: Evolution of Maternal Weight During Pregnancy and Influence on the Endothelial Function in Her Offspring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Childhood Obesity
Keywords: Maternal Obesity
Endothelial Dysfunction
Childhood Obesity
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2016-12-14
Enrollment: 143
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reactive Hyperemia Index (EndoPAT)
timeFrame: Through study completion, average of 18 months
measure: Albumin to creatinin ratio in urine
timeFrame: Through study completion, average of 18 months
measure: Peak response after occlusion (EndoPAT)
timeFrame: Through study completion, average of 18 months
Secondary outcomes:
measure: BMI (kg/m²)
timeFrame: Through study completion, average of 18 months
measure: Body fat percentage
timeFrame: Through study completion, average of 18 months
measure: Insulin resistance
timeFrame: Through study completion, average of 18 months
measure: Inflammatory state of the child (hs-CRP and IL-6)
timeFrame: Through study completion, average of 18 months
measure: Lipid state in blood
timeFrame: Through study completion, average of 18 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: University Hospital of Brussels
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Roland Devlieger, Professor
role: STUDY_DIRECTOR
affiliation: University Hospital of Brussels
name: Inge Gies, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Brussels
name: Karolien Van De Maele, M.D.
role: STUDY_DIRECTOR
References:
citation: Van De Maele K, Gies I, Devlieger R. Effect of bariatric surgery before pregnancy on the vascular function in the offspring: protocol of a cross-sectional follow-up study. BMJ Paediatr Open. 2019 Jan 31;3(1):e000405. doi: 10.1136/bmjpo-2018-000405. eCollection 2019.