Glucose Metabolism in Pregnant Women With a History of Bariatric Surgery, as Well as Three to Six Months After Delivery.
Primary Purpose
Bariatric Surgery Candidate, Pregnancy Complications, Pregnancy Related
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OGTT
IVGTT
1H-magnetic resonance spectroscopy
Sponsored by
About this trial
This is an interventional supportive care trial for Bariatric Surgery Candidate focused on measuring GLP-1, Ectopic Lipids
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Pregnant women with RYGB-operation
Normal weight pregnant women
Obese Pregnant women
Arm Description
Pregnant women with a history of RYGB-Operation were investigated.
Normal weight pregnant women were investigated.
Obese pregnant women were investigated.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03190148
First Posted
June 10, 2017
Last Updated
June 15, 2017
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT03190148
Brief Title
Glucose Metabolism in Pregnant Women With a History of Bariatric Surgery, as Well as Three to Six Months After Delivery.
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
February 13, 2014 (Actual)
Primary Completion Date
April 21, 2016 (Actual)
Study Completion Date
May 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Pregnancy Complications, Pregnancy Related, Glucose Metabolism Disorders
Keywords
GLP-1, Ectopic Lipids
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pregnant women with RYGB-operation
Arm Type
Other
Arm Description
Pregnant women with a history of RYGB-Operation were investigated.
Arm Title
Normal weight pregnant women
Arm Type
Other
Arm Description
Normal weight pregnant women were investigated.
Arm Title
Obese Pregnant women
Arm Type
Other
Arm Description
Obese pregnant women were investigated.
Intervention Type
Other
Intervention Name(s)
OGTT
Intervention Description
A standardized 75g oral Glucose tolerance test was accomplished.
Intervention Type
Other
Intervention Name(s)
IVGTT
Intervention Description
For the exact assessment of Glucose metabolism in the study participants an intravenous Glucose tolerance test (IVGTT) was accomplished
Intervention Type
Other
Intervention Name(s)
1H-magnetic resonance spectroscopy
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
up to 10 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Kautzky-Willer, Univ.Prof.Dr.
Organizational Affiliation
Department of Internal Medicine III, Clinical Division of Endocrinology and Metabolism, Unit of Gender Medicine, Medical University of Vienna
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
30448278
Citation
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.
Results Reference
derived
Learn more about this trial
Glucose Metabolism in Pregnant Women With a History of Bariatric Surgery, as Well as Three to Six Months After Delivery.
We'll reach out to this number within 24 hrs