Impact of Bariatric Surgery on Pregnancy and Glucose Levels
Glucose Homeostasis, Metabolomics and Pregnancy Outcomes After Bariatric Surgery
This study is testing how pregnancy and blood sugar levels are affected in women who have had weight loss surgery compared to those who haven't, to see if it helps with pregnancy outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 190 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 8 sites (Aalst and 7 other locations) |
| Trial ID | NCT05084339 on ClinicalTrials.gov |
What this trial studies
The GLORIA study is a multicenter observational cohort study in Belgium that aims to investigate how altered glucose metabolism and metabolomics during pregnancy after bariatric surgery affect pregnancy outcomes. It will recruit 95 pregnant women who have undergone bariatric surgery and a control group of 95 pregnant women without such surgery. Continuous glucose monitoring (CGM) will be utilized to assess glycaemia levels and variability throughout pregnancy, alongside anthropometric measurements and dietary assessments. The study will also explore the potential of CGM in diagnosing gestational diabetes.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18-45 with a singleton pregnancy and a history of gastric bypass or sleeve gastrectomy.
Not a fit: Patients with multiple pregnancies, pregestational diabetes, or other types of bariatric surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of pregnancy risks for women post-bariatric surgery and enhance monitoring for gestational diabetes.
How similar studies have performed: While similar studies have explored glucose metabolism in pregnancy, this specific approach combining CGM and metabolomics in post-bariatric surgery patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aalst and 7 other locations
- OLV-Aalst-Asse — Aalst, Belgium (Recruiting)
- Uza — Antwerp, Belgium (Recruiting)
- ZNA Antwerpen — Antwerp, Belgium (Recruiting)
- Imelda Bonheiden — Bonheiden, Belgium (Recruiting)
- AZ St-Jan Brugge — Bruges, Belgium (Recruiting)
- UZ Gent — Ghent, Belgium (Recruiting)
- AZ Groeninge Kortrijk — Kortrijk, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Katrien Benhalima, MD PhD — UZ Leuven
- Study coordinator: Katrien Benhalima, MD PhD
- Email: katrien.benhalima@uzleuven.be
- Phone: +3216340614
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.