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

Study Overview
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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.

Official Title
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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

Conditions
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Bariatric Surgery Candidate, Pregnancy Complications, Pregnancy Related, Glucose Metabolism Disorders

Intervention / Treatment
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* Other: OGTT
* Other: IVGTT
* Other: 1H-magnetic resonance spectroscopy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pregnant women with RYGB-operation<br>Pregnant women with a history of RYGB-Operation were investigated. | Other: OGTT<br>* A standardized 75g oral Glucose tolerance test was accomplished.<br>Other: IVGTT<br>* For the exact assessment of Glucose metabolism in the study participants an intravenous Glucose tolerance test (IVGTT) was accomplished<br>Other: 1H-magnetic resonance spectroscopy<br>* 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<br>|
| Other: Normal weight pregnant women<br>Normal weight pregnant women were investigated. | Other: OGTT<br>* A standardized 75g oral Glucose tolerance test was accomplished.<br>Other: IVGTT<br>* For the exact assessment of Glucose metabolism in the study participants an intravenous Glucose tolerance test (IVGTT) was accomplished<br>Other: 1H-magnetic resonance spectroscopy<br>* 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<br>|
| Other: Obese Pregnant women<br>Obese pregnant women were investigated. | Other: OGTT<br>* A standardized 75g oral Glucose tolerance test was accomplished.<br>Other: IVGTT<br>* For the exact assessment of Glucose metabolism in the study participants an intravenous Glucose tolerance test (IVGTT) was accomplished<br>Other: 1H-magnetic resonance spectroscopy<br>* 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<br>|

What is the study measuring?
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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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GLP-1, Ectopic Lipids