Bariatric Surgery and Consequences for Mother and Baby in Pregnancy

NCT03713060 | Completed DMC

• 1 other identifier: SDUSF-2015-203 - (464) -
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hypoglycemia Non-Diabetic; Gastric Bypass Status Complicating Pregnancy, Birth, or Puerperium

Keywords

Pregnancy; Gastric bypass; Hypoglycemia; Gestational weight gain; Fetal growth

Outcome Measures

Primary Outcomes (3)

• Plasma glucose

  Nadir plasma glucose levels during a 4-hour liquid MMT

  Changes in plasma glucose during 4 hour test

• Plasma glucose

  Number of hypoglycemic episodes during CGM

  Nuber of episodes during 14 days monitoring

• Z-score

  Birthweight standard deviation score

  Measured immediately after birth

Study Arms (2)

Women with RYGB and fetus/ child

OTHER

20 pregnant women with previous gastric bypass surgery. During pregnancy the women will be tested with mixed meal test and continuous glucose monitoring for the diagnosis of hypoglycemia. Ultrasounds of fetal growth will be performed and after birth anthropometrics of the newborn will be meaured including a DXA-scan to estimate bodycomposition.

Diagnostic Test: Mixed meal test

Matched controls and fetus/ child

OTHER

20 pregnant women matched on age, prepregnancy-BMI and parity (n = 20). During pregnancy the women will be tested with mixed meal test and continuous glucose monitoring for the diagnosis of hypoglycemia. Ultrasounds of fetal growth will be performed and after birth anthropometrics of the newborn will be meaured including a DXA-scan to estimate bodycomposition.

Diagnostic Test: Mixed meal test

Interventions

Mixed meal test DIAGNOSTIC_TEST

All women will have mixed meal test, continous glucose monitoring and antenatal ultrasounds performed. The children born of these women will have DXA-scans performed after birth.

Also known as: Continous Glucose Monitoring, Antenatal ultrasounds, DXA-scan

Matched controls and fetus/ child; Women with RYGB and fetus/ child

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• GB group: pregnant women with RYGB (n = 20)
• non-GB group: pregnant women matched on age, prepregnancy-BMI and parity (n = 20)
• neonates: offspring of abovementioned women (n = 40)

You may not qualify if:

• multiple pregnancy
• age below 18 and above 45 years
• ongoing smoking and substance abuse
• severe psychiatric disorder
• severe chronic disease
• diabetes
• women with pre-gestational diabetes (type1 or 2) prior to RYGB
• women with Gestational Diabetes Mellitus (GDM) in a previous pregnancy will not be excluded

Sponsors & Collaborators

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

Study Sites (2)

Odense University Hospital

Odense, Fyn, 5000, Denmark

Location

Hospital of South West Jutland

Esbjerg, 6700, Denmark

Location

Related Publications (1)

• Stentebjerg LL, Madsen LR, Stoving RK, Hartmann B, Holst JJ, Vinter C, Juhl CB, Hojlund K, Jensen DM. Altered postprandial glucose metabolism and enteropancreatic hormone responses during pregnancy following Roux-en-Y gastric bypass: a prospective cohort study. BMJ Open Diabetes Res Care. 2025 Mar 20;13(2):e004672. doi: 10.1136/bmjdrc-2024-004672.

  PMID: 40113260 DERIVED

MeSH Terms

Conditions

Hypoglycemia; Gestational Weight Gain

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Louise L Stentebjerg, MD

  Clinical Institue, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

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: Principal investiagtor, MD, PhD-student

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 19, 2018
• Study Start: April 17, 2019
• Primary Completion: July 11, 2022
• Study Completion: July 11, 2022
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)