Glucose Homeostasis, Metabolomics and Pregnancy Outcomes After Bariatric Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
multiple pregnancy
pregnancy ≥12 weeks
other types of bariatric surgery than RYBG or SG
known pregestational diabetes
Trial design
Treatments tested in this trial
- CGM
Treatment groups
190 Participants
are divided into 2 treatment groupsSponsors and collaborators
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
University Hospital, Antwerp
Collaborator
University Hospital, Ghent
Collaborator
Ziekenhuis Netwerk Antwerpen (ZNA)
Collaborator
Onze Lieve Vrouw Hospital
Collaborator
Imelda Hospital, Bonheiden
Collaborator
AZ Sint-Lucas Brugge
Collaborator
General Hospital Groeninge
Collaborator
Source ClinicalTrials.gov