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

June 15, 2017 updated by: Alexandra Kautzky-Willer, Medical University of Vienna

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Pregnant women with RYGB-operation
Pregnant women with a history of RYGB-Operation were investigated.
Other: OGTT
A standardized 75g oral Glucose tolerance test was accomplished.
Other: IVGTT
For the exact assessment of Glucose metabolism in the study participants an intravenous Glucose tolerance test (IVGTT) was accomplished
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
Other: Normal weight pregnant women
Normal weight pregnant women were investigated.
Other: OGTT
A standardized 75g oral Glucose tolerance test was accomplished.
Other: IVGTT
For the exact assessment of Glucose metabolism in the study participants an intravenous Glucose tolerance test (IVGTT) was accomplished
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
Other: Obese Pregnant women
Obese pregnant women were investigated.
Other: OGTT
A standardized 75g oral Glucose tolerance test was accomplished.
Other: IVGTT
For the exact assessment of Glucose metabolism in the study participants an intravenous Glucose tolerance test (IVGTT) was accomplished
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: up to 10 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2014

Primary Completion (Actual)

April 21, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

June 10, 2017

First Submitted That Met QC Criteria

June 15, 2017

First Posted (Actual)

June 16, 2017

Study Record Updates

Last Update Posted (Actual)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 15, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBS-1090

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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