Glucose Homeostasis, Metabolomics and Pregnancy Outcomes After Bariatric Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CGM.
- Who it may be relevant to
- Registry conditions: Bariatric Surgery Status Complicating Pregnancy. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Detailed description
The GLORIA study is a Belgian multicenter prospective cohort study. The investigators aim to recruit 95 pregnant women after bariatric surgery (gastric bypass or sleeve gastrectomy) and as a control group, an age and BMI-matched cohort of 95 pregnant women without bariatric surgery. Participants will be recruited before 12 weeks of pregnancy. To evaluate glucose homeostasis, a masked CGM will be used for 10 days during each trimester in pregnancy and at the time of screening for GDM (at 24-28 weeks). The primary outcome is the mean glycaemia levels and glycaemic variability (SD) measured by CGM in pregnancy. At the different time points, anthropometric measurements (including body composition), food diary, questionnaires and micronutrients will be evaluated. In addition, in collaboration with the lab of Cristina Legido Quigle from the Steno Diabetes Center in Copenhagen, metabolomics will be analyzed. Women with a history of bariatric surgery will receive screening for GDM between 24-28 weeks of pregnancy by performing self- monitoring of blood glucose (SMBG) with a glucometer during one week. In addition to SMBG, women will receive a masked CGM during one week.
Interventions
- Diagnostic test CGM
blinded CGM used at 4 different time points in pregnancy
Primary outcome measures
- mean glycaemia [Time frame: 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 [Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
Secondary outcome measures (12)
- time <54mg/dl [Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- glycaemic variability measured by coefficient of variation (CV) [Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- glycaemic variability measured by mean amplitude of glucose excursions (MAGE) [Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- time <70mg/dl [Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- time <63mg/dl [Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- time <50mg/dl [Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- low blood glucose index (LBGI) [Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- time > 120mg/dl [Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- time > 140mg/dl [Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- time > 180mg/dl [Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- prevalence of gestational diabetes [Time frame: 24-28 weeks of pregnancy]
- gestational weight gain [Time frame: at end of pregnancy]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Belgium · 8 centers
- OLV-Aalst-Asse — Aalst
- UZA — Antwerp
- ZNA Antwerpen — Antwerp
- Imelda Bonheiden — Bonheiden
- AZ St-Jan Brugge — Bruges
- UZ Gent — Ghent
- AZ Groeninge Kortrijk — Kortrijk
- UZ Leuven — Leuven
Publications
- Deleus E, Bochanen N, Ceulemans D, Debunne H, Denys B, Devlieger R, Geerts I, Laenen A, Jochems L, Lannoey E, Lannoo M, Loccufier A, Maes T, Marlier J, Morrens A, Myngheer N, Tierens L, Vandenberghe G, Van den Bruel A, Van den Haute L, Van der Schueren B, Van Pottelbergh I, Benhalima K. Glucose Homeostasis, Metabolomics, and Pregnancy Outcomes After Bariatric Surgery (GLORIA): Protocol for a Multi PMID 40649156
Identifiers
NCT: NCT05084339 · S65734