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临床试验/NCT03190148
NCT03190148已完成不适用

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

Medical University of Vienna0 个研究点目标入组 64 人开始时间: 2014年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
主要终点
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

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant women with a history of RYGB Operation
  • normal weight pregnant women
  • obese pregnant women

排除标准

  • infectious diseases such as Hepatitis B or C, HIV, hematological diseases, acute infections, liver disease, renal disease, cancer

结局指标

主要结局

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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandra Kautzky-Willer

Univ.Prof.Dr.

Medical University of Vienna

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