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Glucose Metabolism in Pregnant Women With a History of Bariatric Surgery, as Well as Three to Six Months After Delivery.

Primary Purpose

Bariatric Surgery Candidate, Pregnancy Complications, Pregnancy Related

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OGTT
IVGTT
1H-magnetic resonance spectroscopy
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bariatric Surgery Candidate focused on measuring GLP-1, Ectopic Lipids

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • pregnant women with a history of RYGB Operation
  • normal weight pregnant women
  • obese pregnant women

Exclusion Criteria:

  • infectious diseases such as Hepatitis B or C, HIV, hematological diseases, acute infections, liver disease, renal disease, cancer

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    Pregnant women with RYGB-operation

    Normal weight pregnant women

    Obese Pregnant women

    Arm Description

    Pregnant women with a history of RYGB-Operation were investigated.

    Normal weight pregnant women were investigated.

    Obese pregnant women were investigated.

    Outcomes

    Primary Outcome Measures

    Assessment of glucose metabolism using an oral Glucose tolerance test (OGTT) and an intravenous Glucose tolerance test (IVGTT) in pregnant women with a history of bariatric surgery, as well as three to six months after delivery
    In this study the Glucose metabolism (including beta cell function, Insulin resistance and Insulin secretion) of pregnant women with a history of bariatric surgery was investigated with an OGTT and an IVGTT between the 24th and the 28th week of pregnancy. In Detail a measurement of the dynamic changes of Glucose, glucagon, C-peptide, Insulin and GLP-1 Levels during the OGTT and the IVGTT in pregnant women with a history of bariatric surgery was done. Three to six months after delivery the OGTT and the IVGTT were repeated and a 1H-magnetic resonance spectroscopy for the measurement of the amount of ectopic lipids in the liver, heart and the muscle was done.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 10, 2017
    Last Updated
    June 15, 2017
    Sponsor
    Medical University of Vienna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03190148
    Brief Title
    Glucose Metabolism in Pregnant Women With a History of Bariatric Surgery, as Well as Three to Six Months After Delivery.
    Official Title
    Explorative Study: Diagnosis and Medical Care of Disturbances of Glucose Metabolism in Pregnant Women With a History of Bariatric Surgery, Normal Weight and Obese Pregnant Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 13, 2014 (Actual)
    Primary Completion Date
    April 21, 2016 (Actual)
    Study Completion Date
    May 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Vienna

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    In this study glucose metabolism of pregnant women with a history of bariatric surgery, obese pregnant women and normal weight pregnant women was investigated. Three to six months after delivery the assessment of Glucose metabolism was repeated and the amount of ectopic lipids in the liver, heart and muscle was measured.
    Detailed Description
    In this study pregnant women with a history of bariatric surgery, normal weight and obese pregnant women were invited to participate. Between the 24th and the 28th week of pregnancy an oral glucose tolerance test (OGTT), as well as an intravenous glucose tolerance test (IVGTT) was conducted. Three to six months after delivery the examinations were repeated. In addition the ectopic lipid content in the liver, heart and the muscle was measured with 1H-magnetic resonance spectroscopy and imaging three to six months post partum. The aim of this study was to compare the glucose metabolism during pregnancy between the three groups as well as to investigate the changes three to six months after delivery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bariatric Surgery Candidate, Pregnancy Complications, Pregnancy Related, Glucose Metabolism Disorders
    Keywords
    GLP-1, Ectopic Lipids

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    64 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pregnant women with RYGB-operation
    Arm Type
    Other
    Arm Description
    Pregnant women with a history of RYGB-Operation were investigated.
    Arm Title
    Normal weight pregnant women
    Arm Type
    Other
    Arm Description
    Normal weight pregnant women were investigated.
    Arm Title
    Obese Pregnant women
    Arm Type
    Other
    Arm Description
    Obese pregnant women were investigated.
    Intervention Type
    Other
    Intervention Name(s)
    OGTT
    Intervention Description
    A standardized 75g oral Glucose tolerance test was accomplished.
    Intervention Type
    Other
    Intervention Name(s)
    IVGTT
    Intervention Description
    For the exact assessment of Glucose metabolism in the study participants an intravenous Glucose tolerance test (IVGTT) was accomplished
    Intervention Type
    Other
    Intervention Name(s)
    1H-magnetic resonance spectroscopy
    Intervention Description
    For the assessment of the ectopic lipid content in the liver, heart and the muscle a 1H-magnetic resonance spectroscopy was accomplished three to six months after delivery
    Primary Outcome Measure Information:
    Title
    Assessment of glucose metabolism using an oral Glucose tolerance test (OGTT) and an intravenous Glucose tolerance test (IVGTT) in pregnant women with a history of bariatric surgery, as well as three to six months after delivery
    Description
    In this study the Glucose metabolism (including beta cell function, Insulin resistance and Insulin secretion) of pregnant women with a history of bariatric surgery was investigated with an OGTT and an IVGTT between the 24th and the 28th week of pregnancy. In Detail a measurement of the dynamic changes of Glucose, glucagon, C-peptide, Insulin and GLP-1 Levels during the OGTT and the IVGTT in pregnant women with a history of bariatric surgery was done. Three to six months after delivery the OGTT and the IVGTT were repeated and a 1H-magnetic resonance spectroscopy for the measurement of the amount of ectopic lipids in the liver, heart and the muscle was done.
    Time Frame
    up to 10 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: pregnant women with a history of RYGB Operation normal weight pregnant women obese pregnant women Exclusion Criteria: infectious diseases such as Hepatitis B or C, HIV, hematological diseases, acute infections, liver disease, renal disease, cancer
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alexandra Kautzky-Willer, Univ.Prof.Dr.
    Organizational Affiliation
    Department of Internal Medicine III, Clinical Division of Endocrinology and Metabolism, Unit of Gender Medicine, Medical University of Vienna
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30448278
    Citation
    Leutner M, Klimek P, Gobl C, Bozkurt L, Harreiter J, Husslein P, Eppel W, Baumgartner-Parzer S, Pacini G, Thurner S, Kautzky-Willer A. Glucagon-like peptide 1 (GLP-1) drives postprandial hyperinsulinemic hypoglycemia in pregnant women with a history of Roux-en-Y gastric bypass operation. Metabolism. 2019 Feb;91:10-17. doi: 10.1016/j.metabol.2018.10.006. Epub 2018 Nov 15.
    Results Reference
    derived

    Learn more about this trial

    Glucose Metabolism in Pregnant Women With a History of Bariatric Surgery, as Well as Three to Six Months After Delivery.

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