RecruitingNot Applicable

Glucose Homeostasis, Metabolomics and Pregnancy Outcomes After Bariatric Surgery

Belgium190 participantsStarted 2023-01-25

Plain-language summary

The aim of the GLORIA study is to determine whether an altered glucose metabolism (with more hypoglycaemia and glycaemic variability) and altered metabolomics during pregnancy after bariatric surgery contribute to the increased risk for adverse pregnancy outcomes such as small-for-gestational age infants. In addition, the investigators also aim to evaluate whether continuous glucose monitoring (CGM) can be used to diagnose gestational diabetes (GDM).

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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Inclusion Criteria: * Age 18-45 years and with a singleton pregnancy with ultrasound-confirmed gestational age up to 11 weeks and 6 days * for the group with bariatric surgery: history of gastric bypass (RYBG) or sleeve gastrectomy (SG) * Participants need to speak and understand Flemish, French or English and have e-mail access. Exclusion Criteria: * multiple pregnancy * pregnancy ≥12 weeks * other types of bariatric surgery than RYBG or SG * known pregestational diabetes * a physical or psychological disease likely to interfere with the conduct of the study * medications known to interfere with glucose metabolism.

What they're measuring

mean glycaemia

Timeframe: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy

Standard deviation of glycaemia

Timeframe: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy

Trial details

NCT IDNCT05084339

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09

Contact for this trial

Katrien Benhalima, MD PhD

+3216340614 katrien.benhalima@uzleuven.be