Glucose Homeostasis, Metabolomics and Pregnancy Outcomes After Bariatric Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
multiple pregnancy
pregnancy ≥12 weeks
other types of bariatric surgery than RYBG or SG
known pregestational diabetes
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
CGM
Diagnostic testblinded CGM used at 4 different time points in pregnancy
Treatment groups
190 Participants
are divided into 2 treatment groupsGroup A: pregnant group with bariatric surgery1 intervention
Group B: matched pregnant group without history of bariatric surgery1 intervention
Trial outcomes
Primary outcomes
1
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 pregnancy2
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 pregnancySecondary outcomes
1
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 pregnancy2
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 pregnancy3
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 pregnancy4
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 pregnancySponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
University Hospital, Antwerp
Collaborator
University Hospital, Ghent
Collaborator
Ziekenhuis Netwerk Antwerpen (ZNA)
Collaborator
Onze Lieve Vrouw Hospital
Collaborator
Imelda Hospital, Bonheiden
Collaborator
AZ Sint-Lucas Brugge
Collaborator
General Hospital Groeninge
Collaborator
Source ClinicalTrials.gov