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

Universitaire Ziekenhuizen KU Leuven

Status

Enrolling

Conditions

Bariatric Surgery Status Complicating Pregnancy

Treatments

Diagnostic Test: CGM

Study type

Observational

Funder types

Other

Identifiers

NCT05084339

S65734

Details and patient eligibility

About

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).

Full 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.

Enrollment

190 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.