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临床试验/NCT05267457
NCT05267457已完成不适用

Associations of Plasma Vanadium Concentrations With Gestational Diabetes Mellitus

Liegang Liu0 个研究点目标入组 504 人开始时间: 2012年8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
504
主要终点
Gestational diabetes mellitus

研究概览

简要总结

Background: Vanadium compounds have been shown to exert insulin-mimetic effects and thereby control glucose homeostasis. However, studies regarding the levels of vanadium and gestational diabetes mellitus (GDM) are limited and have inconsistent outcomes.

Objective: The aim of this study was to investigate the association of plasma vanadium concentrations with gestational diabetes mellitus (GDM).

Design: A hospital-based case-control study was carried out in urban Wuhan, China from August 2012 to April 2015. Pregnant women who screened for GDM at the outpatient clinics of the Department of Endocrinology, Tongji Hospital were invited to participant in the study. The inclusion criteria were as follows: 1) age ≥ 20 and ≤ 43 years; 2) gestational age at GDM screening ≥ 24 weeks; 3) singleton pregnancy. The investigators excluded women who met any of the following items: history of diabetes (including but not limited to GDM), cardiovascular disease, cancer or other systemic diseases; pharmacologic treatment or dietary supplement use that might influence glucose or lipids metabolism; accompanied by other pregnancy complications; incomplete basic information. The diagnosis of GDM can be made if one or more glucose values are above the cut points of 5.1, 10.0 and 8.5 mmol/L at fasting, 1 and 2 h during a 75-gram oral glucose tolerance test (OGTT). Controls were randomly selected and individually matched to cases by age (± 2 years), gestational age (± 2 weeks) and parity. Finally, 252 GDM cases and 252 matched controls were selected in this study. All participants gave written informed consent before enrolling in the study. Fasting blood samples (≥ 8 h overnight fasting) were collected using anticoagulant tubes and centrifuged at 3000 rpm for 5 min. Plasma were separated from blood cells and stored at -80 ℃ for further assay. Plasma vanadium concentrations were measured using inductively coupled plasma mass spectrometry. Conditional logistic regression and restricted cubic spline model were used to evaluate the associations between plasma vanadium and odds of GDM.

研究设计

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

入排标准

年龄范围
20 Years 至 43 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age ≥ 20 and ≤ 43 years;
  • Gestational age at GDM screening ≥ 24 weeks;
  • Singleton pregnancy;

排除标准

  • History of diabetes (including but not limited to GDM), cardiovascular disease, cancer or other systemic diseases;
  • History of receiving pharmacological treatment known to affect glucose metabolism;
  • Incomplete basic information.

结局指标

主要结局

Gestational diabetes mellitus

时间窗: From August 2012 to April 2015

Glucose intolerance with onset or first diagnosis during pregnancy. The diagnosis of GDM can be made if one or more glucose values are above the cut points of 5.1, 10.0 and 8.5 mmol/L at fasting, 1 and 2 h during a 75-gram oral glucose tolerance test.

次要结局

未报告次要终点

研究者

发起方
Liegang Liu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Liegang Liu

Professor

Huazhong University of Science and Technology

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