Clinical trial NCT05084339: Glucose Homeostasis, Metabolomics and Pregnancy Outcomes After Bariatric Surgery
Official title: Glucose Homeostasis, Metabolomics and Pregnancy Outcomes After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery Status Complicating Pregnancy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
name: University Hospital, Ghent
name: Ziekenhuis Netwerk Antwerpen (ZNA)
name: Onze Lieve Vrouw Hospital
name: Imelda Hospital, Bonheiden
name: AZ Sint-Lucas Brugge
name: General Hospital Groeninge
First posted: 2021-10-19
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: mean glycaemia
timeFrame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
measure: Standard deviation of glycaemia
timeFrame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
Secondary outcomes:
measure: time <54mg/dl
timeFrame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
measure: glycaemic variability measured by coefficient of variation (CV)
timeFrame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
measure: glycaemic variability measured by mean amplitude of glucose excursions (MAGE)
timeFrame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
measure: time <70mg/dl
timeFrame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
measure: time <63mg/dl
timeFrame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
measure: time <50mg/dl
timeFrame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
measure: low blood glucose index (LBGI)
timeFrame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
measure: time > 120mg/dl
timeFrame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
measure: time > 140mg/dl
timeFrame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
measure: time > 180mg/dl
timeFrame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
measure: prevalence of gestational diabetes
timeFrame: 24-28 weeks of pregnancy
measure: gestational weight gain
timeFrame: at end of pregnancy
measure: preterm delivery
timeFrame: delivery
measure: cesarean sections
timeFrame: delivery
measure: large-for-gestational age infant
timeFrame: delivery
measure: small-for-gestational infant
timeFrame: delivery
measure: neonatal hypoglycaemia
timeFrame: delivery
measure: Neonatal intensive care admission (NICU)
timeFrame: delivery
measure: gestational hypertension
timeFrame: delivery
measure: pre-eclampsia
timeFrame: delivery
measure: micronutrient deficiencies
timeFrame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy and 30-34 weeks of pregnancy
measure: body fat percentage women
timeFrame: between 6-12 weeks of pregnancy
measure: body fat percentage newborns
timeFrame: within 3 days after birth
measure: fetal abdominal circumference (AC)
timeFrame: at 12, 20, 30 and 34 weeks of gestation
measure: fetal abdominal subcutaneous fat thickness (ASCF)
timeFrame: at 12, 20, 30 and 34 weeks of gestation
measure: placental function
timeFrame: at 12, 20, 30 and 34 weeks of gestation
measure: macronutrient intake baseline
timeFrame: between 6-12 weeks of pregnancy
measure: macronutrient intake in pregnancy
timeFrame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
measure: physical activity
timeFrame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
measure: symptoms of depression
timeFrame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
measure: symptoms of anxiety
timeFrame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
measure: index of quality of life
timeFrame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV-Aalst-Asse
city: Antwerp
country: Belgium
facility: UZA
city: Antwerp
country: Belgium
facility: ZNA Antwerpen
city: Bonheiden
country: Belgium
facility: Imelda Bonheiden
city: Brugge
country: Belgium
facility: AZ St-Jan Brugge
city: Gent
country: Belgium
facility: UZ Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge Kortrijk
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Katrien Benhalima, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: