Effect of HCV Infection on Insulin Resistance and Malnutrition-inflammation Complex Syndrome in Regular Hemodialysis Patients

NCT ID: NCT00527774

Last Updated: 2016-05-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Hepatitis C; Hemodialysis; Quality of Life; Mortality; Hospitalization

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

A

HCV(+) maintenance hemodialysis patients

No interventions assigned to this group

B

HCV(-) maintenance hemodialysis patients

No interventions assigned to this group

Eligibility Criteria

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University

OTHER

Sponsor Role: collaborator

St. Martin De Porress Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chung-Jing Wang, M.D.

Role: STUDY_CHAIR

St. Martin De Porres Hospital

Kuan-Yu Hung, M.D. & Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Nephrology Section, Department of Internal Medicine, National Taiwan University and College of Medicine

Pau-Chung Chen, M.D. & Ph.D.

Role: STUDY_DIRECTOR

Institute of Occupational Medicine and Industrial Hygiene, College of Public Health, National Taiwan University

Locations

Hemodialysis Center, St. Martin De Porres Hospital

Chiayi City, , Taiwan

Countries

Taiwan

Other Identifiers

P0702

Identifier Type: -

Identifier Source: org_study_id