NCT03713060: BAMBI

Bariatric Surgery and Consequences for Mother and Baby in Pregnancy

Completed NA Last updated 18 July 2022

What this trial tests

NA trial testing Mixed meal test in Hypoglycemia Non-Diabetic in 46 participants. Completed in 11 July 2022.

Timeline

17 April 2019

Primary endpoint
11 July 2022

11 July 2022

Quick facts

Lead sponsor	University of Southern Denmark
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	46
Start date	17 April 2019
Primary completion	11 July 2022
Estimated completion	11 July 2022
Sites	2 locations across Denmark

Drugs / interventions tested

• Mixed meal test — full drug profile →

Conditions studied

• Hypoglycemia Non-Diabetic — all drugs for Hypoglycemia Non-Diabetic →
• Gastric Bypass Status Complicating Pregnancy, Birth, or Puerperium — all drugs for Gastric Bypass Status Complicating Pregnancy, Birth, or Puerperium →

Sponsor

University of Southern Denmark

Who can join

Adults 18 to 45, female only, with Hypoglycemia Non-Diabetic or Gastric Bypass Status Complicating Pregnancy, Birth, or Puerperium. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background Roux-en-Y gastric bypass (RYGB) is a well-established treatment of obesity, most often performed in women during their reproductive years. Adverse events related to RYGB include hypoglycemia. Though usually attenuated in pregnancy, the incretin response is reinforced in subjects with RYGB and the resulting changes in insulin and glucagon responses together with the resultant weight loss are possible underlying mechanisms for hypoglycemia. The majorities of women who have undergone RYGB conceive shortly after RYGB and have an increased risk for inappropriate gestational weight gain (GWG) and thereby fetal growth restriction. However, studies of hypoglycemia and GWG in pregnant women following RYGB are lacking.

Objective In women with previous RYGB we aim to investigate a) glucose level and incretin response during a mixed meal test (MMT) in early and late pregnancy, b) trimester specific incidence of postprandial hypoglycemia and c) fetal growth.

Methods 20 women with RYGB and 20 age-, BMI- and parity-matched controls will be studied with a) 2nd and 3rd trimester 4-hour liquid MMTs, b) 6-days Continuous Glucose Monitoring (CGM) once every trimester and post partum and c) maternal and fetal anthropometrics including antenatal ultrasound examinations and neonatal DXA-scans. The primary outcomes are nadir plasma glucose levels during the 4-hour liquid MMT, number of hypoglycemic episodes during CGM and birthweight standard deviation scores.

Discussion A better understanding of maternal metabolism and fetal growth in women with RYGB will support risk stratification, patient information and management both before and during pregnancy.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Roux-en-Y Gastric Bypass Increases Glycemic Excursions During Pregnancy and Postpartum: A Prospective Cohort Study.
   Stentebjerg LL, Madsen LR, Støving RK, Andersen LLT, et al · · 2023 · cited 27× · PMID 36477853 · DOI 10.2337/dc22-1357
2. 58^th EASD Annual Meeting of the European Association for the Study of Diabetes : Stockholm, Sweden, 19 - 23 September 2022.
   · 2022 · cited 6× · PMID 35920845 · DOI 10.1007/s00125-022-05755-w
3. Altered postprandial glucose metabolism and enteropancreatic hormone responses during pregnancy following Roux-en-Y gastric bypass: a prospective cohort study.
   Stentebjerg LL, Madsen LR, Støving RK, Hartmann B, et al · · 2025 · cited 2× · PMID 40113260 · DOI 10.1136/bmjdrc-2024-004672
4. Maternal Hypoglycemia and Reduced Foetal Growth in Pregnancies Following Roux-en-Y Gastric Bypass: A Prospective Cohort Study.
   Stentebjerg LL, Madsen LR, Støving RK, Andersen LLT, et al · · 2026 · PMID 42108404 · DOI 10.1111/dom.70852