Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pregnancy Following Gastric Bypass - Consequences for Mother and Child

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03713060
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Louise Stentebjerg, University of Southern Denmark

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.


Condition or disease Intervention/treatment Phase
Hypoglycemia Non-Diabetic Gastric Bypass Status Complicating Pregnancy, Birth, or Puerperium Diagnostic Test: Mixed meal test Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Effect of Gastric Bypass Surgery on Glucose Metabolism, Gestational Weight Gain and Fetal Growth in Subsequent Pregnancy
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : December 21, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arm Intervention/treatment
Women with RYGB and fetus/ child
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
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.
Other Names:
  • Continous Glucose Monitoring
  • Antenatal ultrasounds
  • DXA-scan

Matched controls and fetus/ child
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
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.
Other Names:
  • Continous Glucose Monitoring
  • Antenatal ultrasounds
  • DXA-scan




Primary Outcome Measures :
  1. Plasma glucose [ Time Frame: Changes in plasma glucose during 4 hour test ]
    Nadir plasma glucose levels during a 4-hour liquid MMT

  2. Plasma glucose [ Time Frame: Nuber of episodes during 14 days monitoring ]
    Number of hypoglycemic episodes during CGM

  3. Z-score [ Time Frame: Measured immediately after birth ]
    Birthweight standard deviation score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • multiple pregnancy
  • age below 18 and above 45 years
  • ongoing smoking and substance abuse
  • severe psychiatric disorder
  • severe chronic disease
  • 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 Gestational Diabetes Mellitus (GDM) in a previous pregnancy will not be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713060


Contacts
Layout table for location contacts
Contact: Louise L Stentebjerg, MD +4540258265 lstentebjerg@health.sdu.dk
Contact: Dorte M Jensen, MD +4522267933 Dorte.Moeller.Jensen@rsyd.dk

Locations
Layout table for location information
Denmark
Odense University Hospital Recruiting
Odense, Fyn, Denmark, 5000
Contact: Louise L Stentebjerg, MD    +4540258265    Louise.Laage.Stentebjerg2@rsyd.dk   
Contact: Dorte M Jensen, MD       Dorte.Moeller.Jensen@rsyd.dk   
Hospital of South West Jutland Recruiting
Esbjerg, Denmark, 6700
Contact: Louise L Stentebjerg, MD    +4540258265    Louise.Laage.Stentebjerg2@rsyd.dk   
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Louise L Stentebjerg, MD Clinical Institue, University of Southern Denmark

Layout table for additonal information
Responsible Party: Louise Stentebjerg, Principal investiagtor, MD, PhD-student, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03713060     History of Changes
Other Study ID Numbers: SDUSF-2015-203 - (464) -
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Louise Stentebjerg, University of Southern Denmark:
Pregnancy
Gastric bypass
Hypoglycemia
Gestational weight gain
Fetal growth

Additional relevant MeSH terms:
Layout table for MeSH terms
Pregnancy Complications
Hypoglycemia
Gestational Weight Gain
Glucose Metabolism Disorders
Metabolic Diseases
Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms