Bariatric Surgery Status Complicating Pregnancy
Conditions
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.
Interventions
DIAGNOSTIC_TESTCGM
blinded CGM used at 4 different time points in pregnancy
Sponsors
Universitaire Ziekenhuizen KU Leuven
University Hospital, Antwerp
University Hospital, Ghent
Ziekenhuis Netwerk Antwerpen (ZNA)
Onze Lieve Vrouw Hospital
Imelda Hospital, Bonheiden
AZ Sint-Lucas Brugge
General Hospital Groeninge
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 <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 |
| 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 <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 |
| 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 |
| 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 |
| 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 |
| prevalence of gestational diabetes | 24-28 weeks of pregnancy | gestational diabetes based on capillairy monitoring or oral glucose tolerance test |
| gestational weight gain | at end of pregnancy | total gestational weight gain in pregnancy |
| preterm delivery | delivery | delivery \<37 weeks of pregnancy |
| cesarean sections | delivery | planned and emergency cesarean sections combined |
| 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 |
| neonatal hypoglycaemia | delivery | neonatal hypoglycaemia requiring intravenous dextrose |
| Neonatal intensive care admission (NICU) | delivery | NICU admission defined as requiring a duration of at least 24 h |
| 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) |
| 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 |
| 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 |
| 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 baseline | between 6-12 weeks of pregnancy | food diary taken in early pregnancy |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Belgium
Contacts
CONTACTKatrien Benhalima, MD PhD
CONTACTEllen Deleus, MD
PRINCIPAL_INVESTIGATORKatrien Benhalima, MD PhD
UZ Leuven
Outcome results
None listed