Quality of Life Clinical Trial
Official title:
Impact of Hepatitis C Virus Infection on Insulin Resistance and Inflammatory Biomarkers in Patients With Maintenance Hemodialysis
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.
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.
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