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).
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
190
blinded CGM used at 4 different time points in pregnancy
OLV-Aalst-Asse
Aalst, Belgium
RECRUITINGUZA
Antwerp, Belgium
RECRUITINGZNA Antwerpen
Antwerp, Belgium
mean glycaemia
mean glycaemia measured by CGM
Time frame: 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
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
time \<54mg/dl measured by CGM
Time frame: 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
Time frame: 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
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
time \<70mg/dl measured by CGM
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
time \<63mg/dl measured by CGM
Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Imelda Bonheiden
Bonheiden, Belgium
RECRUITINGAZ St-Jan Brugge
Bruges, Belgium
RECRUITINGUZ Gent
Ghent, Belgium
RECRUITINGAZ Groeninge Kortrijk
Kortrijk, Belgium
RECRUITINGUZ Leuven
Leuven, Belgium
RECRUITINGtime <50mg/dl
time \<50mg/dl measured by CGM
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)
low blood glucose index (LBGI) based on CGM
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
time \>120mg/dl measured by CGM
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
time \>140mg/dl measured by CGM
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
time \>180mg/dl measured by CGM
Time frame: 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
Time frame: 24-28 weeks of pregnancy
gestational weight gain
total gestational weight gain in pregnancy
Time frame: at end of pregnancy
preterm delivery
delivery \<37 weeks of pregnancy
Time frame: delivery
cesarean sections
planned and emergency cesarean sections combined
Time frame: 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
Time frame: delivery
small-for-gestational infant
gestational age adjusted birth weight \<10th percentile according to the standardized Flemish birth charts adjusted for parity and sex
Time frame: delivery
neonatal hypoglycaemia
neonatal hypoglycaemia requiring intravenous dextrose
Time frame: delivery
Neonatal intensive care admission (NICU)
NICU admission defined as requiring a duration of at least 24 h
Time frame: delivery
gestational hypertension
gestational hypertension ≥20 weeks of gestation: blood pressure ≥140/90mmHg
Time frame: 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)
Time frame: delivery
micronutrient deficiencies
vitamin A, vitamin D, B12, folate, prothrombin time and iron
Time frame: 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
Time frame: between 6-12 weeks of pregnancy
body fat percentage newborns
body fat calculated by measurements of skinfolds at triceps, flank and subscapular
Time frame: within 3 days after birth
fetal abdominal circumference (AC)
fetal abdominal circumference (AC) to evaluate fetal body composition
Time frame: 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
Time frame: 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.
Time frame: at 12, 20, 30 and 34 weeks of gestation
macronutrient intake baseline
food diary taken in early pregnancy
Time frame: between 6-12 weeks of pregnancy
macronutrient intake in pregnancy
frequency food questionnaire
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy