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NCT Number: NCT05084339

Glucose Homeostasis, Metabolomics and Pregnancy Outcomes After Bariatric Surgery

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).

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Key information

Conditions

Bariatric Surgery Status Complicating Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

OLV-Aalst-Asse, Aalst, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CGM

Diagnostic Test

blinded CGM used at 4 different time points in pregnancy

Primary outcomes

  1. 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

    mean glycaemia measured by CGM

  2. 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

    SD measured by CGM

Secondary outcomes

  1. 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

    time <54mg/dl measured by CGM

  2. 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

    CV measured by CGM

  3. 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

    MAGE measured by CGM

  4. 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 <70mg/dl measured by CGM

  5. 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 <63mg/dl measured by CGM

  6. 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

    time <50mg/dl measured by CGM

  7. 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

    low blood glucose index (LBGI) based on CGM

  8. 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 >120mg/dl measured by CGM

  9. 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 >140mg/dl measured by CGM

  10. 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

    time >180mg/dl measured by CGM

  11. prevalence of gestational diabetes

    Time frame: 24-28 weeks of pregnancy

    gestational diabetes based on capillairy monitoring or oral glucose tolerance test

  12. gestational weight gain

    Time frame: at end of pregnancy

    total gestational weight gain in pregnancy

  13. preterm delivery

    Time frame: delivery

    delivery <37 weeks of pregnancy

  14. cesarean sections

    Time frame: delivery

    planned and emergency cesarean sections combined

  15. large-for-gestational age infant

    Time frame: delivery

    gestational age adjusted birth weight >90th percentile according to the standardized Flemish birth charts adjusted for parity and sex

  16. small-for-gestational infant

    Time frame: delivery

    gestational age adjusted birth weight <10th percentile according to the standardized Flemish birth charts adjusted for parity and sex

  17. neonatal hypoglycaemia

    Time frame: delivery

    neonatal hypoglycaemia requiring intravenous dextrose

  18. Neonatal intensive care admission (NICU)

    Time frame: delivery

    NICU admission defined as requiring a duration of at least 24 h

  19. gestational hypertension

    Time frame: delivery

    gestational hypertension ≥20 weeks of gestation: blood pressure ≥140/90mmHg

  20. pre-eclampsia

    Time frame: delivery

    pre-eclampsia [≥20 weeks of gestation: new onset of hypertension and proteinuria or the new onset of hypertension and significant end-organ dysfunction with or without proteinuria (dipstick ≥ 2+, ≥0.3 g protein/24 hours or ≥30 mg/dL protein in spot urine or spot urine protein / creatinine ratio ≥30 mg protein/mmol creatinine)

  21. micronutrient deficiencies

    Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy and 30-34 weeks of pregnancy

    vitamin A, vitamin D, B12, folate, prothrombin time and iron

  22. body fat percentage women

    Time frame: between 6-12 weeks of pregnancy

    body fat measured by bioelectrical impedance analysis

  23. body fat percentage newborns

    Time frame: within 3 days after birth

    body fat calculated by measurements of skinfolds at triceps, flank and subscapular

  24. fetal abdominal circumference (AC)

    Time frame: at 12, 20, 30 and 34 weeks of gestation

    fetal abdominal circumference (AC) to evaluate fetal body composition

  25. fetal abdominal subcutaneous fat thickness (ASCF)

    Time frame: at 12, 20, 30 and 34 weeks of gestation

    fetal abdominal subcutaneous fat thickness (ASCF) to evaluate fetal body composition

  26. placental function

    Time frame: at 12, 20, 30 and 34 weeks of gestation

    the pulsatility index (PI) of the Doppler wave in the arteriae uterinae at 12 weeks and in the arteria umbilicalis at 20, 30 and 34 weeks of gestation.

  27. macronutrient intake baseline

    Time frame: between 6-12 weeks of pregnancy

    food diary taken in early pregnancy

  28. macronutrient intake in pregnancy

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

    frequency food questionnaire

  29. physical activity

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

    the Kaiser physical activity survey

  30. symptoms of depression

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

    the 20-item Center for Epidemiologic Studies-Depression (CES-D) questionnaire

  31. symptoms of anxiety

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

    six-item short-form the State-Trait Anxiety Inventory (STAI) questionnaire on anxiety

  32. index of quality of life

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

    36-Item Short Form Health Survey (SF-36) questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Ellen Deleus, MD

CONTACT

[email protected]

Katrien Benhalima, MD PhD

CONTACT

[email protected]

+3216340614

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • AZ Sint-Lucas Brugge
  • General Hospital Groeninge
  • Imelda Hospital, Bonheiden
  • Onze Lieve Vrouw Hospital
  • University Hospital, Antwerp
  • University Hospital, Ghent
  • Ziekenhuis Netwerk Antwerpen (ZNA)

Registry information

Acronym: GLORIA

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 19, 2021
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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