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Clinical Study of Serum Fetuin A Level, Insulin Resistance and Hepatic Fat Content in Dialysis Patients

2011年10月20日 更新者:Hung-Yuan Chen、Far Eastern Memorial Hospital

The Association of Serum Fetuin A Level, Insulin Resistance and Hepatic Fat Content and Their Associations With Overall Survival in Maintenance Hemodialysis and Peritoneal Dialysis Patients

Background Fetuin A, synthesized in hepatocyte, is a circulatory inhibitor of precipitation of calcium and phosphate and links to cardiovascular calcification and mortality in dialysis patients; besides, it is associated with insulin resistance in general population. Hepatic fat accumulation enhanced fetuin A secretion in animal model.

Objects This study is designed to investigate the association of fetuin A level, insulin resistance and hepatic fat content in dialysis patients. Besides, we planed to observe the survival of dialysis patient with different hepatic fat content.

Methods. This is a prospective observational study. Three hundred and fifty ESRD patients undergoing maintenance HD or PD will be recruited for this prospective investigation. All the participants will receive baseline abdominal ultrasound for estimation of hepatic fat content. Hepatic fat content will be estimated as minimal, mild, moderate or severe according to the Hepburn classification. Besides, all participants also check baseline fetuin A, HOMA-IR, hs-CRP, adiponectin, leptin and lipid profiles (T-CHO, TG, LDL-C, HDL-C), nutritional parameter and other biochemical parameters. All participants will be followed for 4 years for survival analysis. The outcomes are all-cause mortality and composite CV mortality.

Expected results Dialysis patients with higher hepatic fat may have higher fetuin A levels which may lead to long-term survival benefits.

研究概览

地位

未知

条件

详细说明

Background:

Fetuin A is a protein secreted by hepatocytes that inhibits insulin receptor tyrosine kinase of adipose and muscle cells (1, 2). Recently, its inhibitory potency on calcium phosphate precipitation has been linked to cardio-vascular (CV) calcification and has predicted CV and non-CV mortality in dialysis patients (3, 4). In most investigations, fetuin A deficiency is associated with higher mortality, worse CV outcomes in dialysis patients. In our recent study, fetuin A deficiency is also linked to vascular access failure in hemodialysis (HD) patients (5). The pathogenesis of worse survival in these fetuin A deficiency dialysis patients is not well-known. Nevertheless, the associations of fetuin A deficiency and progression of vascular calcification and atherosclerosis are thought to be the possible mechanism of the high CV mortality (6, 7).

In general population, fetuin A is associated with insulin resistance, metabolic syndrome and obesity, that is, human with higher fetuin A concentration has higher insulin resistance (8). Insulin resistance, diabetes and metabolic syndrome are all important predictors of long-term CV outcome in general population (9, 10). In an interventional study performed in diabetic human with normal kidney function, treatment with pioglitazone seems to decrease fetuin A levels and enhance insulin sensitivity (11). In an animal model, mice with fatty liver presented up-regulated fetuin A (Ahsg) mRNA expression (1, 2). In non-diabetic subjects, fetuin A is associated with hepatic fat accumulation and insulin resistance (12). Moreover, in a recent investigation, fetuin A concentration was associated with body fat mass in chronic kidney disease (CKD) patients not yet receiving dialysis (13). In our previous investigation, we also found HD patients with higher fetuin A concentration have higher risk to be truncal obesity and hypertriglyceridemia (14). These studies suggested this liver-secreted protein rapidly responds to hepatic fat accumulation which inhibits generation of adiponectin in adipose tissue; therefore higher fetuin-A and lower adiponectin may contribute to obesity-induced insulin resistance and development of diabetes in general population and CKD patients (15). However, this relationship has not been shown in dialysis patients.

Although obesity, metabolic syndrome contributed to higher CV mortality in general population (9, 10); patients under dialysis with higher BMI experienced short-term survival benefit (16). It is so-called "reverse epidemiology" in dialysis patients. Generally speaking, well-nutrition dialysis patients experienced less malnutrition-inflammation complex and therefore, their short-term survival benefit from being well-nutrition overcomes the long-term survival disadvantage brought from over-nutrition such as obesity and insulin resistance. However, ESRD patients with abdominal obesity still have higher CV mortality risk (17).The interesting part of the results these investigations is that, fetuin A deficiency in dialysis patients have worse CV outcome; on the contrary, higher fetuin A level leads to insulin resistance and thereafter higher CV mortality in general population. It is not clear that whether the fetuin A concentration is another "reverse epidemiology" in dialysis patients. But dialysis patients with well-nutrition, presented with higher BMI, more hepatic fat accumulation have better survival. We hypothesize the survival disadvantages of fetuin A deficiency, which is frequently present in dialysis patients, may have a major impact on mortality in a shorter period of time; and increased hepatic fat-accumulation (over-nutrition) may leads to fetuin A secretion and overwhelms the short-term negative effects of fetuin A deficiency on survival, finally, leading to a protective effect of high BMI, hepatic fat accumulation or over-nutrition on overall survival in dialysis patients.

Study purposes:

This study is designed to:

  1. To evaluate the association of hepatic fat content and fetuin A concentration in maintenance HD/PD patients
  2. To evaluate the association of fetuin A concentration and insulin resistance markers in HD/PD patients
  3. To evaluate the overall survival (4-year) of HD/PD patients with different content of hepatic fat

Study designs and methods:

This is a prospective observational study. Three hundred and fifty ESRD patients undergoing maintenance HD or PD for more than 6 months will be recruited for this prospective investigation.

All the participants will receive baseline abdominal ultrasound for estimation of hepatic fat content. Hepatic fat content will be estimated as minimal, mild, moderate or severe according to the Hepburn classification: absent (affecting 0% to 2% of the hepatocytes), minimal (2% to 10%), mild (10% to 30%), moderate (30% to 60%), and severe (more than 60% of the hepatocytes). We choose abdominal ultrasound as the method of hepatic fat estimation rather than MRI and CT which are the gold standard of hepatic fat estimation, because the limited use of MRI in dialysis patients and increased cancer risk receiving screening CT. Besides, all participants also check baseline fetuin A, HOMA-IR, hs-CRP, adiponectin, leptin and lipid profiles (T-CHO, TG, LDL-C, HDL-C), nutritional parameter and other biochemical parameters. All participants will be followed for 4 years for survival analysis. The outcomes are all-cause mortality and composite CV mortality.

研究类型

观察性的

注册 (预期的)

300

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • New Taipei City、台湾
        • 招聘中
        • Far Eastern Memorial Hospital
        • 接触:
      • New Taipei city、台湾
        • 完全的
        • Far Eastern Memorial Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Three hundred and fifty ESRD patients undergoing maintenance HD or PD will be recruited for this prospective investigation.

描述

Inclusion Criteria:

  1. ESRD patients undergoing maintenance HD or PD for more than 6 months
  2. Age>20

Exclusion Criteria:

  1. Recent hospitalization duet active medical or psychiatric problems
  2. Active malignancy
  3. Patient refusal

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
liver fat contents

研究衡量的是什么?

主要结果指标

结果测量
大体时间
liver fat contents, fetuin A levels
大体时间:1 year
1 year

次要结果测量

结果测量
大体时间
CV and all-cause mortality
大体时间:4 years
4 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Hung-Yuan Chen, MD、Far Eastern Memorial Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年1月1日

初级完成 (预期的)

2014年1月1日

研究完成 (预期的)

2014年1月1日

研究注册日期

首次提交

2011年10月20日

首先提交符合 QC 标准的

2011年10月20日

首次发布 (估计)

2011年10月24日

研究记录更新

最后更新发布 (估计)

2011年10月24日

上次提交的符合 QC 标准的更新

2011年10月20日

最后验证

2011年10月1日

更多信息

与本研究相关的术语

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