Glucose Homeostasis, Metabolomics and Pregnancy Outcomes After Bariatric Surgery (GLORIA)

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).

Study Overview

• Status: Recruiting
• Conditions: Bariatric Surgery Status Complicating Pregnancy
• Intervention / Treatment: Diagnostic test: CGM

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.

• Study Type: Observational
• Enrollment (Anticipated): 190

Contacts and Locations

• Study Contact: Name: Katrien Benhalima, MD PhD; Phone Number: +3216340614; Email: katrien.benhalima@uzleuven.be
• Study Contact Backup: Name: Ellen Deleus, MD; Email: ellen.deleus@uzleuven.be

Study Locations

• Belgium
  • Aalst, Belgium
    • Recruiting
    • OLV-Aalst-Asse
    • Contact: Inge Van Pottelbergh, MD PhD
  • Antwerp, Belgium
    • Recruiting
    • UZA
    • Contact: Eveline Dirinck, MS PhD
  • Antwerp, Belgium
    • Recruiting
    • ZNA Antwerpen
    • Contact: Astrid Morrens, MD
  • Bonheiden, Belgium
    • Recruiting
    • Imelda Bonheiden
    • Contact: Els Lannoey, MD
  • Brugge, Belgium
    • Recruiting
    • AZ St-Jan Brugge
    • Contact: Anne Loccufier, MD
  • Gent, Belgium
    • Recruiting
    • UZ Gent
    • Contact: Kristien Roelens, MD PhD
  • Leuven, Belgium
    • Recruiting
    • UZ Leuven
    • Contact: Katrien Benhalima, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pregnant group with bariatric surgery; pregnant women with a history of gastric bypass or sleeve gastrectomy	Diagnostic test: CGM; 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	Diagnostic test: CGM; blinded CGM used at 4 different time points in pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
time <54mg/dl	time <54mg/dl 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
glycaemic variability measured by coefficient of variation (CV)	CV 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
glycaemic variability measured by mean amplitude of glucose excursions (MAGE)	MAGE 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
time <70mg/dl	time <70mg/dl 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
time <63mg/dl	time <63mg/dl 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
time <50mg/dl	time <50mg/dl 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
low blood glucose index (LBGI)	low blood glucose index (LBGI) based on CGM	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	time >120mg/dl 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
time > 140mg/dl	time >140mg/dl 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
time > 180mg/dl	time >180mg/dl 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
prevalence of gestational diabetes	gestational diabetes based on capillairy monitoring or oral glucose tolerance test	24-28 weeks of pregnancy
gestational weight gain	total gestational weight gain in pregnancy	at end of pregnancy
preterm delivery	delivery <37 weeks of pregnancy	delivery
cesarean sections	planned and emergency cesarean sections combined	delivery
large-for-gestational age infant	gestational age adjusted birth weight >90th percentile according to the standardized Flemish birth charts adjusted for parity and sex	delivery
small-for-gestational infant	gestational age adjusted birth weight <10th percentile according to the standardized Flemish birth charts adjusted for parity and sex	delivery
neonatal hypoglycaemia	neonatal hypoglycaemia requiring intravenous dextrose	delivery
Neonatal intensive care admission (NICU)	NICU admission defined as requiring a duration of at least 24 h	delivery
gestational hypertension	gestational hypertension ≥20 weeks of gestation: blood pressure ≥140/90mmHg	delivery
pre-eclampsia	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)	delivery
micronutrient deficiencies	vitamin A, vitamin D, B12, folate, prothrombin time and iron	between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy and 30-34 weeks of pregnancy
body fat percentage women	body fat measured by bioelectrical impedance analysis	between 6-12 weeks of pregnancy
body fat percentage newborns	body fat calculated by measurements of skinfolds at triceps, flank and subscapular	within 3 days after birth
fetal abdominal circumference (AC)	fetal abdominal circumference (AC) to evaluate fetal body composition	at 12, 20, 30 and 34 weeks of gestation
fetal abdominal subcutaneous fat thickness (ASCF)	fetal abdominal subcutaneous fat thickness (ASCF) to evaluate fetal body composition	at 12, 20, 30 and 34 weeks of gestation
placental function	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.	at 12, 20, 30 and 34 weeks of gestation
macronutrient intake baseline	food diary taken in early pregnancy	between 6-12 weeks of pregnancy
macronutrient intake in pregnancy	frequency food questionnaire	between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
physical activity	the Kaiser physical activity survey	between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
symptoms of depression	the 20-item Center for Epidemiologic Studies-Depression (CES-D) questionnaire	between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
symptoms of anxiety	six-item short-form the State-Trait Anxiety Inventory (STAI) questionnaire on anxiety	between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
index of quality of life	36-Item Short Form Health Survey (SF-36) questionnaire	between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: University Hospital, Ghent; University Hospital, Antwerp; Imelda Hospital, Bonheiden; Onze Lieve Vrouw Hospital; Ziekenhuis Netwerk Antwerpen (ZNA); AZ St- Jan Brugge
• Investigators: Principal Investigator: Katrien Benhalima, MD PhD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2023
• Primary Completion (Anticipated): September 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications
• Other Study ID Numbers: S65734

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No