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

NCT ID: NCT03190148

Last Updated: 2017-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-13

Study Completion Date

2016-05-01

Brief Summary

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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

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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.

Conditions

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Bariatric Surgery Candidate Pregnancy Complications Pregnancy Related Glucose Metabolism Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pregnant women with RYGB-operation

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

Group Type OTHER

OGTT

Intervention Type OTHER

A standardized 75g oral Glucose tolerance test was accomplished.

IVGTT

Intervention Type OTHER

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

1H-magnetic resonance spectroscopy

Intervention Type OTHER

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 women

Normal weight pregnant women were investigated.

Group Type OTHER

OGTT

Intervention Type OTHER

A standardized 75g oral Glucose tolerance test was accomplished.

IVGTT

Intervention Type OTHER

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

1H-magnetic resonance spectroscopy

Intervention Type OTHER

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

Obese Pregnant women

Obese pregnant women were investigated.

Group Type OTHER

OGTT

Intervention Type OTHER

A standardized 75g oral Glucose tolerance test was accomplished.

IVGTT

Intervention Type OTHER

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

1H-magnetic resonance spectroscopy

Intervention Type OTHER

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

Interventions

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OGTT

A standardized 75g oral Glucose tolerance test was accomplished.

Intervention Type OTHER

IVGTT

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

Intervention Type OTHER

1H-magnetic resonance spectroscopy

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Alexandra Kautzky-Willer

Univ.Prof.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexandra Kautzky-Willer, Univ.Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

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

References

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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.

Reference Type DERIVED
PMID: 30448278 (View on PubMed)

Other Identifiers

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PBS-1090

Identifier Type: -

Identifier Source: org_study_id

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