Glucose Homeostasis, Metabolomics and Pregnancy Outcomes After Bariatric Surgery
- Conditions
- Bariatric Surgery Status Complicating Pregnancy
- Interventions
- Diagnostic Test: CGM
- Registration Number
- NCT05084339
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 190
- 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.
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description matched pregnant group without history of bariatric surgery CGM age-and BMI matched pregnant women without history of bariatric surgery pregnant group with bariatric surgery CGM pregnant women with a history of gastric bypass or sleeve gastrectomy
- Primary Outcome Measures
Name Time Method Standard deviation of glycaemia 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
mean glycaemia 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
- Secondary Outcome Measures
Name Time Method glycaemic variability measured by mean amplitude of glucose excursions (MAGE) 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
time <50mg/dl 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
preterm delivery delivery delivery \<37 weeks of pregnancy
large-for-gestational age infant delivery gestational age adjusted birth weight \>90th percentile according to the standardized Flemish birth charts adjusted for parity and sex
small-for-gestational infant delivery gestational age adjusted birth weight \<10th percentile according to the standardized Flemish birth charts adjusted for parity and sex
body fat percentage women between 6-12 weeks of pregnancy body fat measured by bioelectrical impedance analysis
body fat percentage newborns within 3 days after birth body fat calculated by measurements of skinfolds at triceps, flank and subscapular
time <54mg/dl 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
glycaemic variability measured by coefficient of variation (CV) 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
time <70mg/dl 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
low blood glucose index (LBGI) 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
cesarean sections delivery planned and emergency cesarean sections combined
gestational hypertension delivery gestational hypertension ≥20 weeks of gestation: blood pressure ≥140/90mmHg
pre-eclampsia 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)
symptoms of depression 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
index of quality of life 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
time <63mg/dl 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
time > 140mg/dl 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
time > 180mg/dl 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
gestational weight gain at end of pregnancy total gestational weight gain in pregnancy
neonatal hypoglycaemia delivery neonatal hypoglycaemia requiring intravenous dextrose
time > 120mg/dl 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
prevalence of gestational diabetes 24-28 weeks of pregnancy gestational diabetes based on capillairy monitoring or oral glucose tolerance test
Neonatal intensive care admission (NICU) delivery NICU admission defined as requiring a duration of at least 24 h
macronutrient intake baseline between 6-12 weeks of pregnancy food diary taken in early pregnancy
micronutrient deficiencies 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
fetal abdominal circumference (AC) at 12, 20, 30 and 34 weeks of gestation fetal abdominal circumference (AC) to evaluate fetal body composition
fetal abdominal subcutaneous fat thickness (ASCF) at 12, 20, 30 and 34 weeks of gestation fetal abdominal subcutaneous fat thickness (ASCF) to evaluate fetal body composition
placental function 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.
macronutrient intake in pregnancy 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
symptoms of anxiety 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
physical activity 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
Trial Locations
- Locations (8)
Imelda Bonheiden
🇧🇪Bonheiden, Belgium
AZ St-Jan Brugge
🇧🇪Brugge, Belgium
UZA
🇧🇪Antwerp, Belgium
OLV-Aalst-Asse
🇧🇪Aalst, Belgium
UZ Gent
🇧🇪Gent, Belgium
ZNA Antwerpen
🇧🇪Antwerp, Belgium
AZ Groeninge Kortrijk
🇧🇪Kortrijk, Belgium
UZ Leuven
🇧🇪Leuven, Belgium