Glucose Homeostasis, Metabolomics and Pregnancy Outcomes After Bariatric Surgery

NCT ID: NCT05084339

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 190 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-25
• Study Completion Date: 2025-12-31

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).

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.

Conditions

Bariatric Surgery Status Complicating Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

pregnant group with bariatric surgery

pregnant women with a history of gastric bypass or sleeve gastrectomy

CGM

Intervention Type: DIAGNOSTIC_TEST

blinded CGM used at 4 different time points in pregnancy

matched pregnant group without history of bariatric surgery

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

CGM

Intervention Type: DIAGNOSTIC_TEST

blinded CGM used at 4 different time points in pregnancy

Interventions

CGM

blinded CGM used at 4 different time points in pregnancy

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: collaborator

Ziekenhuis Netwerk Antwerpen (ZNA)

OTHER

Sponsor Role: collaborator

Onze Lieve Vrouw Hospital

OTHER

Sponsor Role: collaborator

Imelda Hospital, Bonheiden

OTHER

Sponsor Role: collaborator

AZ Sint-Lucas Brugge

OTHER

Sponsor Role: collaborator

General Hospital Groeninge

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katrien Benhalima, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

OLV-Aalst-Asse

Aalst, , Belgium

Site Status: RECRUITING

UZA

Antwerp, , Belgium

Site Status: RECRUITING

ZNA Antwerpen

Antwerp, , Belgium

Site Status: RECRUITING

Imelda Bonheiden

Bonheiden, , Belgium

Site Status: RECRUITING

AZ St-Jan Brugge

Bruges, , Belgium

Site Status: RECRUITING

UZ Gent

Ghent, , Belgium

Site Status: RECRUITING

AZ Groeninge Kortrijk

Kortrijk, , Belgium

Site Status: RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Katrien Benhalima, MD PhD

Role: CONTACT

katrien.benhalima@uzleuven.be

+3216340614

Ellen Deleus, MD

Role: CONTACT

ellen.deleus@uzleuven.be

Facility Contacts

Inge Van Pottelbergh, MD PhD

Role: primary

Eveline Dirinck, MS PhD

Role: primary

Astrid Morrens, MD

Role: primary

Els Lannoey, MD

Role: primary

Anne Loccufier, MD

Role: primary

Kristien Roelens, MD PhD

Role: primary

Nele Myngheer

Role: primary

Katrien Benhalima, MD PhD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 40649156 (View on PubMed)

Other Identifiers

S65734

Identifier Type: -

Identifier Source: org_study_id