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

Pregnancy Related Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03190148
• Other study ID #: PBS-1090
• Status: Completed
• Phase: N/A
• First received: June 10, 2017
• Last updated: June 15, 2017
• Start date: February 13, 2014
• Est. completion date: May 1, 2016

Study information

• Verified date: June 2017
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 1, 2016
• Est. primary completion date: April 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Glucose Metabolism Disorders
• Metabolic Diseases
• Pregnancy Complications
• Pregnancy Related

Intervention

Other:
• OGTT
A standardized 75g oral Glucose tolerance test was accomplished.
• IVGTT
For the exact assessment of Glucose metabolism in the study participants an intravenous Glucose tolerance test (IVGTT) was accomplished
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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