RecruitingNCT05084339

Glucose Homeostasis, Metabolomics and Pregnancy Outcomes After Bariatric Surgery


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

190 participants

Start Date

Jan 25, 2023

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria3

  • 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 Criteria6

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTCGM

blinded CGM used at 4 different time points in pregnancy


Locations(8)

OLV-Aalst-Asse

Aalst, Belgium

UZA

Antwerp, Belgium

ZNA Antwerpen

Antwerp, Belgium

Imelda Bonheiden

Bonheiden, Belgium

AZ St-Jan Brugge

Bruges, Belgium

UZ Gent

Ghent, Belgium

AZ Groeninge Kortrijk

Kortrijk, Belgium

UZ Leuven

Leuven, Belgium

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05084339


Related Trials