跳至主要内容
临床试验/NCT04054843
NCT04054843已完成不适用

Afamin Levels in First Trimester Pregnancies With Gestational Diabetes Mellitus

Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Maternal plasma afamin levels In first trimester GDM prediction

研究概览

简要总结

This study includes pregnancies in 11 to 14 th gestational weeks. Investigators will sample maternal plasma in the first trimester and analyze maternal plasma afamin values. All these women will then be screened by two step OGTT. Investigators will compare afamin levels in GDM and control groups.

详细描述

Background Gestational diabetes mellitus (GDM) is an endocrinopathy that occurs during pregnancy, and presents several clinical findings together with increased blood glucose levels. The frequency of GDM differs, while the incidence of the disease in Turkey is reported to be 7%. Most of the societies recommend screening all women with or without any risk factors in terms of GDM. The definitive diagnosis is made via oral glucose challenge test (OGTT). Early diagnosis and treatment are the key points to improve maternal and fetal outcomes. Different biomarkers are studied regarding GDM diagnosis starting from first trimester. However, there is not a worldwide accepted biomarker for defining the high risk group to the date. Afamin is known as an important indicator of oxidative stress. Moreover, oxidative stress itself is strongly associated with insulin resistance and obesity which are responsible from GDM pathogenesis.

Objective To investigate the association between first trimester maternal plasma afamin levels and GDM. Also, investigators aimed to understand the role of afamin for the prediction of GDM in this study.

Methods This is an observational prospective cohort study conducted in Department of Perinatology, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital, University of Health Sciences, Ankara, Turkey. During 11 and 14 weeks of gestational, maternal blood will be obtained from eligible pregnant women, and samples will be stored at -80 oC. Informed written consent will be obtained from participants. Between 24th and 28th gestational weeks, all these women will be screened by two step OGTT. Then, afamin levels will be compared in GDM and control groups. Exclusion criteria are; multiple pregnancy, fetal anomalies, pregestational diabetes, underlying chronic diseases (hypertension, thyroid dysfunction, other endocrinopathies, autoimmune disorders), age <18 or > 35 years, fasting glucose level > 105 mg/dL or random glucose level > 200 mg/dL.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • multiple pregnancy
  • fetal anomalies
  • pregestational diabetes
  • underlying chronic diseases (hypertension, thyroid dysfunction, other endocrinopathies, autoimmune disorders)
  • age <18 or > 35 years
  • fasting glucose level > 105 mg/dL or random glucose level > 200 mg/dL

结局指标

主要结局

Maternal plasma afamin levels In first trimester GDM prediction

时间窗: 6 months

The predictive value of first trimester maternal plasma afamin levels for the diagnosis of gestational diabetes mellitus in comparison with two step OGTT

次要结局

未报告次要终点

研究者

发起方
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aykan Yucel, Professor, M.D.

Professor

Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

研究点 (1)

Loading locations...

相似试验