The BAMBI II Study

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.

Conditions

• Hypo- and Hyperglycemia Following Bariatric Surgery
• Association Between Glucose Excursions, Fetal Growth and Neonatal Body Composition

Interventions

DEVICE

CGM

The CGM will meausre glucose continously for 10 days.

DEVICE

Activity tracker

Counts daily number of steps and register any physical acitivity

BIOLOGICAL

Blood samples

vitamin status,, hæmoglobin, HbA1c

DIAGNOSTIC_TEST

UL

standard measurements to follow fetal growth during pregnancy

Sponsors & Collaborators

• University of Southern Denmark

  collaborator OTHER

• Region of Southern Denmark

  collaborator OTHER

• Odense University Hospital

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-01

Primary Completion

2028-02-01

Completion

2028-02-01

Countries

• Denmark

Study Locations