The BAMBI II Study

NCT07578597 | Enrolling By Invitation DMC

• 1 other identifier: 0009-0006-5088-8054
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bariatric surgery; Gestational diabetes; Pregnancy; Pregnancy following bariatric surgery; Glucose excursions; PeaPod; CGM

Outcome Measures

Primary Outcomes (2)

• Trimester-specific occurrence of hypo- and hyperglycemia

  Time spent with hypo- and hyperclycemia according to trimester and 6-8 weeks postpartum

  trimester specific CGM mesurements for 10 days

• Association between glucose excursions, fetal growth and neonatal body composition

  glucose measurements accoriding to birth weight and body compisiotion of the newborn measured by PeaPod

  trimester specific and 6-8 weeks postpartum

Study Arms (4)

1. visit - 1. trimester

EXPERIMENTAL

The participants have measured antropetric values and blood pressure. A sensor is applied for continous glucose measurements in 10 days. Blood samples are drawn to evalute vitaminstatus, HbA1c among others. The participant will also fill out qustionaires of diet, mental og physicial health.

Device: CGM; Device: Activity tracker; Biological: Blood samples; Diagnostic Test: UL

2. visit - 2. trimester

EXPERIMENTAL

The participants have measured antropetric values and blood pressure. A sensor is applied for continous glucose measurements in 10 days. Blood samples are drawn to evalute vitaminstatus, HbA1c among others. The participant will also fill out qustionaires of diet, mental og physicial health.

Device: CGM; Device: Activity tracker; Biological: Blood samples; Diagnostic Test: UL

3. visit - 3. trimester

EXPERIMENTAL

The participants have measured antropetric values and blood pressure. A sensor is applied for continous glucose measurements in 10 days. Blood samples are drawn to evalute vitaminstatus, HbA1c among others. The participant will also fill out qustionaires of diet, mental og physicial health.

Device: CGM; Device: Activity tracker; Biological: Blood samples; Diagnostic Test: UL

4. visit 6-8 weeks postpartum

EXPERIMENTAL

The participants have measured antropetric values and blood pressure. A sensor is applied for continous glucose measurements in 10 days. Blood samples are drawn to evalute vitaminstatus, HbA1c among others. The participant will also fill out qustionaires of diet, mental og physicial health.

Device: CGM; Device: Activity tracker; Biological: Blood samples

Interventions

UL DIAGNOSTIC_TEST

standard measurements to follow fetal growth during pregnancy

1. visit - 1. trimester; 2. visit - 2. trimester; 3. visit - 3. trimester

Blood samples BIOLOGICAL

vitamin status,, hæmoglobin, HbA1c

1. visit - 1. trimester; 2. visit - 2. trimester; 3. visit - 3. trimester; 4. visit 6-8 weeks postpartum

CGM DEVICE

The CGM will meausre glucose continously for 10 days.

1. visit - 1. trimester; 2. visit - 2. trimester; 3. visit - 3. trimester; 4. visit 6-8 weeks postpartum

Activity tracker DEVICE

Counts daily number of steps and register any physical acitivity

1. visit - 1. trimester; 2. visit - 2. trimester; 3. visit - 3. trimester; 4. visit 6-8 weeks postpartum

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 pre-gestational diabetes (type1 or 2) prior to RYGB
• women with GDM in a previous pregnancy will not be excluded

Sponsors & Collaborators

• Odense University Hospital: lead
• Region of Southern Denmark: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Steno Diabetes Center, Odsense Univeristy Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Fitness Trackers; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Prospective, cohort study

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start: April 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

DK (1)