Glucose Homeostasis, Metabolomics and Pregnancy Outcomes After Bariatric Surgery

NCT05084339 | Recruiting

• 1 other identifier: S65734
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 8

Brief 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).

Conditions

Bariatric Surgery Status Complicating Pregnancy

Outcome Measures

Primary Outcomes (2)

• mean glycaemia

  mean glycaemia measured by CGM

  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

  SD measured by CGM

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

Secondary Outcomes (32)

• time <54mg/dl

  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)

  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)

  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

  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

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

Study Arms (2)

pregnant group with bariatric surgery

pregnant women with a history of gastric bypass or sleeve gastrectomy

Diagnostic Test: CGM

matched pregnant group without history of bariatric surgery

age-and BMI matched pregnant women without history of bariatric surgery

Diagnostic Test: CGM

Interventions

CGM DIAGNOSTIC_TEST

blinded CGM used at 4 different time points in pregnancy

matched pregnant group without history of bariatric surgery; pregnant group with bariatric surgery

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

95 pregnant women with a history of bariatric surgery (RYBG or SG) and 95 age-and BMO matched pregnant women without history of bariatric surgery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 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
• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (8)

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

Related Publications (1)

• 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 Multicentre Prospective Cohort Study. J Clin Med. 2025 Jul 7;14(13):4782. doi: 10.3390/jcm14134782.

  PMID: 40649156 DERIVED

Study Officials

• Katrien Benhalima, MD PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrien Benhalima, MD PhD

CONTACT

+3216340614; katrien.benhalima@uzleuven.be

Ellen Deleus, MD

CONTACT

ellen.deleus@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 19, 2021
• Study Start: January 25, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (8)