Clinical Trial

The BAMBI II Study

Enrolling by Invitation
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Summary
Background Bariatric surgery (BS) is an efficient treatment of severe obesity and diseases like female infertility. Almost half of the population having BS are women of reproductive age, and BMI above 35 kg/m2 and infertility even serve as eligibility for surgery. BS improves fertility, however with risk of adverse effects on maternal glucose regulation and fetal growth. Objective We hypothesize that pregnant women with BS have a higher frequency of both hypo- and hyperglycemia causing abnormal fetal growth, and that Roux-en-Y gastric bypass (RYGB) results in higher risk of hypoglycemia and larger glucose variability than sleeve gastrectomy (SG). Methods In this prospective, multicenter study, we will include 225 pregnant BMI, age, and parity-matched women from four obstetric departments: 75 with RYGB, 75 with SG and 75 without BS. Data include continuous glucose monitoring, activity tracking, blood sampling, questionnaires, and fetal growth. Discussion Knowledge on prevalence, clinical significance and treatment of maternal glucose excursions and fetal growth in pregnancy following BS are lacking. This study will help clinicians improve the care of pregnant women with BS and to guide women of reproductive age considering BS.
Trial Details
NCT Number NCT07578597
Lead Sponsor Odense University Hospital
Collaborators: Region of Southern Denmark, University of Southern Denmark
Conditions Hypo- and Hyperglycemia Following Bariatric Surgery, Association Between Glucose Excursions, Fetal Growth and Neonatal Body Composition
Enrollment 225 participants
Start Date 2025-04-01
Primary Completion 2028-02-01 (estimated)
Study Completion 2028-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-11