The BAMBI II Study
Enrolling by invitation · Not applicable
Conditions studied: Hypo- and Hyperglycemia Following Bariatric Surgery, Association Between Glucose Excursions, Fetal Growth and Neonatal Body Composition
In brief
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.
Key facts
- Study ID
- NCT07578597
- Run by
- Odense University Hospital
- People needed
- 225
- Starts
- 2025-04-01
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2026-05-11
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may not qualify if…
- multiple pregnancy
- age below 18 and above 45 years
- ongoing smoking or substance abuse
- severe psychiatric disorder or chronic disease
- use of GLP-1 analogue within two months of conception
- diabetes
- women with overt diabetes at inclusion (HbA1c ≥ 48 mmol/l and/or fasting p-glucose ≥ 7 mmol/l)
- women with pre-gestational diabetes (type1 or 2) prior to RYGB
- women with GDM in a previous pregnancy will not be excluded
Where it is running
- Steno Diabetes Center, Odsense Univeristy Hospital — Odense, Denmark
Full record on ClinicalTrials.gov
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