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Clinical Trials/NCT02992106
NCT02992106
Completed
Not Applicable

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

Universitair Ziekenhuis Brussel1 site in 1 country143 target enrollmentMay 10, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endothelial Dysfunction
Sponsor
Universitair Ziekenhuis Brussel
Enrollment
143
Locations
1
Primary Endpoint
Reactive Hyperemia Index (EndoPAT)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 10, 2017
End Date
March 18, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Inge Gies

Pediatric Endocrinologist

Universitair Ziekenhuis Brussel

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.

Outcomes

Primary Outcomes

Reactive Hyperemia Index (EndoPAT)

Time Frame: 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)

Time Frame: 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

Time Frame: Through study completion, average of 18 months

Albumin to creatinin ratio is considered an early marker of endothelial cell dysfunction

Secondary Outcomes

  • Insulin resistance(Through study completion, average of 18 months)
  • Lipid state in blood(Through study completion, average of 18 months)
  • Body fat percentage(Through study completion, average of 18 months)
  • BMI (kg/m²)(Through study completion, average of 18 months)
  • Inflammatory state of the child (hs-CRP and IL-6)(Through study completion, average of 18 months)

Study Sites (1)

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