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Protocol
Effect of bariatric surgery before pregnancy on the vascular function in the offspring: protocol of a cross-sectional follow-up study
  1. Karolien Van De Maele1,2,
  2. Inge Gies1,
  3. Roland Devlieger2,3
  1. 1 Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels, Belgium
  2. 2 Research Unit Organ Systems, Department of Development and Regeneration, Katholieke Universiteit Leuven Groep Biomedische Wetenschappen, Leuven, Belgium
  3. 3 Department of Obstetrics and Gynecology, Universitaire Ziekenhuizen Leuven, Leuven, Belgium
  1. Correspondence to Karolien Van De Maele; karolien.vandemaele{at}uzbrussel.be

Abstract

Background The offspring of obese pregnant women are at risk for adverse metabolic, inflammatory and cardiovascular programming. Comprehensive long-term data are lacking on the contribution of changes in maternal weight after bariatric surgery before pregnancy compared with lifestyle interventions during pregnancy on the cardiovascular programming of the offspring.

Methods EFFECTOR is designed as a cross-sectional cohort follow-up study targeting the children of different groups of women who were previously studied during their pregnancy. Four subgroups of children are identified, based on maternal weight characteristics during pregnancy: normal weight women, obese women without any intervention and obese women who underwent a lifestyle intervention during or bariatric surgery before pregnancy. Data collection is performed as a single study visit at home. Data on the sociodemographic situation, food habits and psychomotor development are obtained through questionnaires. During the home visit, extensive anthropometric and vascular assessment is performed. Information on body composition is provided by assessment of body weight and height, bioelectrical impedance analysis, skinfold measurements and ultrasound. Endothelial function is measured by non-invasive peripheral arterial tonometry (EndoPAT 2000). Biomarkers performed in blood and urinalysis conclude the data collection process.

Trial registration number NCT02992106 (Pre-results).

  • obesity
  • vascular disease
  • metabolic
  • endocrinology

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjpo-2018-000405

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    Footnotes

    • Contributors KVDM, IG and RD contributed to the design of the study. KVDM wrote the manuscript. IG and RD did a critical revision of the manuscript. The funding organisations performed a peer-review of the protocol.

    • Funding The research activities of KVDM are funded by a doctoral research grant from the Belgian Society for Pediatric Endocrinology and Diabetology (BESPEED) and additional research funding from Wetenschappelijk Fonds Willy Gepts of the UZ Brussel.

    • Competing interests None declared.

    • Patient consent Not required.

    • Ethics approval The study obtained approval from the central Ethics Committee UZ Brussels, which provides final ethical approval (22 February 2017), and the local Ethics Committee UZ Leuven/KU Leuven. The Faces Pain Scale was added as an amendment, which was approved by the Ethics Committee (15 January 2018). Changes to the study protocol will be submitted to the Ethics Committee and will not be performed before obtaining an approval.

    • Provenance and peer review Not commissioned; externally peer reviewed.