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临床试验/NCT04325126
NCT04325126Unknown不适用

Retinol-binding Protein 4 (RBP4) Metabolizm in Type 2 Diabetes Progression and Associated Cardiovascular Complications

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
serum RBP4 level

研究概览

简要总结

Retinol-binding protein 4 (RBP4) may affects obesity development and the development of obesity-related diseases including insulin resistance, type 2 diabetes, steatohepatitis and cardiovascular disease. This study aims to examine the involvement of RBP4 in patients with diagnosed diabetes, diabetic cardiovascular disease, pre-diabetes (pre-DM) and healthy controls during the progression of T2DM, and to evaluate the ability of RBP4 to predict cases of diabetes with an elevated risk of cardiovascular complications . Along with animal experiment.

详细描述

A total of 500 Chinese patients admitted to the First Affliated Hospital of Xi'an Jiaotong University (Xi'an, China) between March 2020 and March 2022 were recruited to investigate the RBP4 profles. Peripheral blood samples are drawn at the initial medical examination, in the morning after a fast of at least 8 h, and immediately stored at -80˚C until the sphingolipid measurements were performed.

Blood pressure, WC, hip circumference (HC), body weight and body height were measured by a trained physician. The participants enrolled in the study provided written informed consent.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fasting plasma glucose (FPG)≥7.0 mmol/l;
  • 2 h plasma glucose (2hPG) ≥11.1 mmol/l;
  • glycated hemoglobin (HbA1c) level ≥6.5%;
  • random plasma glucose ≥11.1 mmol/l plus symptoms of hyperglycemia;
  • T2DM diagnosed previously.
  • Pre-DM was defned as follows:
  • FPG ≥5.6-6.9 mmol/l
  • 2hPG 7.8-11.0 mmol/l
  • HbA1c 5.7-6.4%.

排除标准

  • type 1 diabetes
  • liver or kidney disorders.

结局指标

主要结局

serum RBP4 level

时间窗: 2022.3

serum RBP4 level in DM, pre-DM, CVD, DM-CVD and healthy controls.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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