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Clinical Trials in Denmark / NCT07578597
Enrolling by invitation Not applicable

The BAMBI II Study

NCT07578597 · tracked via the Priya Life Science Denmark tracker
Sponsor
Odense University Hospital
Phase
Not applicable
Started
2025-04-01
Last updated
2026-05-11

Condition(s) studied

Hypo- and Hyperglycemia Following Bariatric SurgeryAssociation Between Glucose Excursions, Fetal Growth and Neonatal Body Composition

Investigational drug(s) / intervention(s)

CGMActivity trackerBlood samples →UL

CGM: The CGM will meausre glucose continously for 10 days.

Activity tracker: Counts daily number of steps and register any physical acitivity

Blood samples: vitamin status,, hæmoglobin, HbA1c

UL: standard measurements to follow fetal growth during pregnancy

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
* RYGB group: pregnant women with RYGB and their neonate (n = 75) * SG group: pregnant women with SG and their neonate (n = 75) * non-BS group: pregnant women without BS matched on age, pre-pregnancy-BMI and parity and their neonate (n = 75) Exclusion criteria * 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

Primary outcome measure(s)

  • Trimester-specific occurrence of hypo- and hyperglycemia — trimester specific CGM mesurements for 10 days
    Time spent with hypo- and hyperclycemia according to trimester and 6-8 weeks postpartum
  • Association between glucose excursions, fetal growth and neonatal body composition — trimester specific and 6-8 weeks postpartum
    glucose measurements accoriding to birth weight and body compisiotion of the newborn measured by PeaPod

Trial sites (1)

FacilityCityRegionStatus
Steno Diabetes Center, Odsense Univeristy Hospital Odense Denmark

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07578597 on ClinicalTrials.gov ↗ ← All trials in Denmark