NCT03190148

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2016

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

2.2 years

First QC Date

June 10, 2017

Last Update Submit

June 15, 2017

Conditions

Bariatric Surgery CandidatePregnancy ComplicationsPregnancy RelatedGlucose Metabolism Disorders

Keywords

GLP-1Ectopic Lipids

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 10 months

Study Arms (3)

Pregnant women with RYGB-operation

OTHER

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

Other: OGTTOther: IVGTTOther: 1H-magnetic resonance spectroscopy

Normal weight pregnant women

OTHER

Normal weight pregnant women were investigated.

Other: OGTTOther: IVGTTOther: 1H-magnetic resonance spectroscopy

Obese Pregnant women

OTHER

Obese pregnant women were investigated.

Other: OGTTOther: IVGTTOther: 1H-magnetic resonance spectroscopy

Interventions

OGTTOTHER

A standardized 75g oral Glucose tolerance test was accomplished.

Normal weight pregnant womenObese Pregnant womenPregnant women with RYGB-operation
IVGTTOTHER

For the exact assessment of Glucose metabolism in the study participants an intravenous Glucose tolerance test (IVGTT) was accomplished

Normal weight pregnant womenObese Pregnant womenPregnant women with RYGB-operation
1H-magnetic resonance spectroscopyOTHER

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

Normal weight pregnant womenObese Pregnant womenPregnant women with RYGB-operation

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30448278DERIVED

MeSH Terms

Conditions

Pregnancy ComplicationsGlucose Metabolism Disorders

Interventions

Glucose Tolerance TestProton Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative TechniquesMagnetic Resonance SpectroscopySpectrum AnalysisChemistry Techniques, Analytical

Study Officials

  • Alexandra Kautzky-Willer, Univ.Prof.Dr.

    Department of Internal Medicine III, Clinical Division of Endocrinology and Metabolism, Unit of Gender Medicine, Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.Prof.Dr.

Study Record Dates

First Submitted

June 10, 2017

First Posted

June 16, 2017

Study Start

February 13, 2014

Primary Completion

April 21, 2016

Study Completion

May 1, 2016

Last Updated

June 16, 2017

Record last verified: 2017-06