Glucose Homeostasis, Metabolomics and Pregnancy Outcomes After Bariatric Surgery

Last updated: May 7, 2024
Sponsor: Universitaire Ziekenhuizen KU Leuven
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Treatment

CGM

Clinical Study ID

NCT05084339
S65734
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18-45 years and with a singleton pregnancy with ultrasound-confirmed gestationalage up to 11 weeks and 6 days
  • for the group with bariatric surgery: history of gastric bypass (RYBG) or sleevegastrectomy (SG)
  • Participants need to speak and understand Flemish, French or English and have e-mailaccess.

Exclusion

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.

Study Design

Total Participants: 190
Treatment Group(s): 1
Primary Treatment: CGM
Phase:
Study Start date:
January 25, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • OLV-Aalst-Asse

    Aalst,
    Belgium

    Active - Recruiting

  • UZA

    Antwerp,
    Belgium

    Active - Recruiting

  • ZNA Antwerpen

    Antwerp,
    Belgium

    Active - Recruiting

  • Imelda Bonheiden

    Bonheiden,
    Belgium

    Active - Recruiting

  • AZ St-Jan Brugge

    Brugge,
    Belgium

    Active - Recruiting

  • UZ Gent

    Gent,
    Belgium

    Active - Recruiting

  • AZ Groeninge Kortrijk

    Kortrijk,
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven,
    Belgium

    Active - Recruiting

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