跳至主要内容
临床试验/NCT01671605
NCT01671605已完成不适用

Mechanisms of CKD-Induced Foam Cell Formation

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
1
主要终点
In Vitro Lipoprotein Functions

研究概览

简要总结

There is currently little understanding of macrophage cholesterol homeostasis and foam cell formation across the spectrum of CKD. We hypothesize that an inverse relationship exist between the severity of CKD and processes underlying foam cell formation, and that the relationship becomes independent of serum lipoprotein levels as renal function declines. We propose to systematically examine scavenger receptors and cholesterol uptake as well as cholesterol transporters and efflux mechanisms in individuals with normal renal function, patients with moderate CKD. We further propose to determine if processed contributing to foam cell formation are related to the plasma lipid profile and if the relationship is modified by co-morbidities, such as diabetes, obesity, systemic inflammation which are common in this population and directly influence vascular integrity. These data will be critically important to understand when the abnormality starts and will provide crucial information.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Patients with moderate degree of CKD, or patients with advanced CKD or control subjects with intact kidney function
  • Male or female
  • All ethnic groups
  • ≥ 18 years and have signed informed consent

排除标准

  • Pregnancy and current smoking
  • Rheumatoid arthritis and systemic lupus erythematosus
  • History of active or chronic hepatitis B, history of active or chronic hepatitis C, human immunodeficiency virus (HIV)
  • For moderate CKD subjects: nephrotic syndrome
  • For control subjects: nephrotic syndrome, patients with estimated GFR < 60 mL/min/1.73 m^2, or proteinuria

结局指标

主要结局

In Vitro Lipoprotein Functions

时间窗: Once, at enrollment

Cholesterol efflux. Baseline and outcome measurements are the same. The cholesterol efflux was measured once using HDL isolated from CKD and control patients. There was no intervention,this assessment was performed once in each group. The measurement of cholesterol efflux is performed by an in vitro assay in cultured cells. Cells are loaded with cholesterol and maintained for 72 hours. The media of the cultured cells is then changed and the new media contains HDL from CKD or control patients. In additional cells, no HDL is added. The cells are maintained for 24 hours, and intracellular cholesterol is assessed. The cholesterol efflux represents the amount of cholesterol that was leached by HDL from each of our study groups. Thus, cells not exposed to any HDL will contain the highest intracellular cholesterol content. The amount of cholesterol in cells exposed to CKD HDL or control HDL reflects the efflux capacity of that HDL. This is expressed as percent of cholesterol removed by HDL.

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

Valentina Kon

Principal Investigator

Vanderbilt University

研究点 (1)

Loading locations...

相似试验