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临床试验/NCT00527774
NCT00527774已完成不适用

Impact of Hepatitis C Virus Infection on Insulin Resistance and Inflammatory Biomarkers in Patients With Maintenance Hemodialysis

St. Martin De Porress Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1

研究概览

简要总结

The purpose of this study is to study whether hepatitis C virus (HCV)infected maintenance hemodialysis (MHD)patients have distinct metabolic, inflammatory and adipokine characteristics that can be linked to poor clinical outcome and to examine the hypothesis that HCV infected MHD patients with metabolic syndrome have higher risks for hospitalization, cardiovascular and all-cause mortality.

详细描述

Background: High prevalence of hepatitis C virus (HCV) infection is noticed in Yun-Lin, Chiayi area in Taiwan. Patients with maintenance hemodialysis (MHD) in this area have the highest risk for HCV infection. Understanding the natural history of HCV and its association with inflammation, nutrition and outcomes in dialysis patients may provide more information for anti-HCV management strategies in dialysis and other patient populations.

Objective

We hypothesize that HCV infected MHD patients have distinct metabolic, and inflammatory characteristics that can be linked to adverse conditions and increased higher morbidity and mortality.

Design: A cross-sectional study is conducted in one regional teaching hospital with its medical alliance dialysis clinics. A cohort of 200 MHD patients including 70 HCV subjects are recruited. Basic data and dialysis characteristics are collected. Metabolic syndrome (MS) is defined according to International Diabetes Federation (IDF) consensus 2005. Insulin resistance (IR) is defined by HOMA index. Comorbidity is rated by Charlson Comorbidity Score. Malnutrition-inflammation score (MIS) is used to rate the severity of malnutrition-inflammation complex syndrome (MICS). Nutritional and appetite status are evaluated by appetite and diet assessment tool (ADAT) and anthropometric evaluation. Inflammatory status is measured by biomarkers such as serum concentrations of C-reactive protein, tumor necrosis factor-α, interleukin-1β, interleukin-6, adiponectin, leptin and plasminogen activator inhibitor-1. Ankle-brachial index (ABI)test is used to predict the severity of peripheral arterial occlusive disease (PAOD). We use Beck's depression inventory to assess depression status and apply SF36, WHOQOL and EQ-5D questionnaires to assess health-related quality of life (HRQOL). Outcome evaluations are based on mortality and hospitalizations followed prospectively for up to 6 months.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The main inclusion criteria were those outpatients who were undergoing MHD for at least 8 weeks, were 18 years or older, and who signed the written consent form.

排除标准

  • Patients with a clinical or laboratory evidence of active infectious diseases in the last 1 month before inclusion in the study, or life expectancy of less than 6 months, for example, because of a metastatic malignancy or terminal HIV disease, were excluded.

研究者

发起方
St. Martin De Porress Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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