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临床试验/NCT04390711
NCT04390711已完成不适用

An Observational Cross-sectional Study to Compare Carbamylated High-density Lipoprotein Levels Among Normal Subjects, Type 2 Diabetes Mellitus Patients With and Without Coronary Heart Disease.

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 282 人开始时间: 2018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
入组人数
282
试验地点
1
主要终点
Carbamylated-HDL levels alteration between the control and the T2DM patients with and without concomitant CAD.

研究概览

简要总结

This is an observational cross-sectional study aimed at investigating the alterations of the carbamylated-HDL levels in T2DM patients, and comparing the concentration of carbamylated-HDL between the T2DM patients with CAD and without CAD to explore the association between carbamylated-HDL and risk of CAD in T2DM patients.

详细描述

High-density lipoprotein (HDL) is involved in various atheroprotective processes, including reverse cholesterol transport, inhibition of lipid oxidation and inflammatory cytokine secretion, endothelial repair, and antiapoptotic function, which all contribute to the regression of plague burden. Recent studies have shown that oxidative stress and chronic inflammation - both implicated in the process of diabetes - can contribute to an irreversible post-translational modification called carbamylation. Carbamylation levels reflect the burden of enhanced inflammation, oxidative stress, and renal impairment, and can serve as a biomarker of certain pathological conditions. Several clinical studies have demonstrated positive associations between cardiovascular risk, mortality, and serum carbamylation-derived product levels in the general population and particularly in patients with kidney failure. Increasing evidence also shows that carbamylated lipoprotein plays a pivotal role in atherosclerosis.18 However, most studies concerning carbamylation have been performed under a kidney disease background. Whether HDL particles in patients with type 2 diabetes mellitus (T2DM) show enhanced carbamylation and whether this enhancement is associated with vascular complications remains unknown. Thus, in the present study, the investigators aim to test whether HDL experiences carbamylation in T2DM patients and investigated the pro-atherogenic effects of carbamylated HDL on endothelial-monocyte adhesion.

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
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1:Clinical diagnosis of T2DM (according to the criteria of the American Diabetes Association.)

排除标准

  • end-stage renal disease (ESRD)
  • acute coronary syndrome,
  • heart failure,
  • chronic viral or bacterial infection,
  • immune system disorders

结局指标

主要结局

Carbamylated-HDL levels alteration between the control and the T2DM patients with and without concomitant CAD.

时间窗: within 1week after enrollment

HDL was isolated from subjects' plasma and its carbamylation levels were further detected by the enzyme-linked immunosorbent assay

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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