![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
St. Martin De Porress Hospital National Taiwan University |
---|---|
Information provided by: | St. Martin De Porress Hospital |
ClinicalTrials.gov Identifier: | NCT00527774 |
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.
Condition |
---|
Hepatitis C Hemodialysis Quality of Life Mortality Hospitalization |
Study Type: | Observational |
Study Design: | Natural History, Cross-Sectional, Defined Population, Prospective Study |
Official Title: | Impact of Hepatitis C Virus Infection on Insulin Resistance and Inflammatory Biomarkers in Patients With Maintenance Hemodialysis |
Estimated Enrollment: | 200 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | September 2007 |
Groups/Cohorts |
---|
A: Case
HCV(+) maintenance hemodialysis patients
|
B: Control
HCV(-) maintenance hemodialysis patients
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hung-Bin Tsai, M.D. | 886-5-2756000 ext 3615 | hbtsai@ms32.hinet.net |
Taiwan | |
Hemodialysis Center, St. Martin De Porres Hospital | Recruiting |
Chiayi City, Taiwan, 60076 | |
Contact: Hung-Bin Tsai, M.D. 886-5-2756000 ext 3615 hbtsai@ms32.hinet.net | |
Principal Investigator: Chung-Jing Wang, M.D. |
Study Chair: | Chung-Jing Wang, M.D. | St. Martin De Porres Hospital |
Principal Investigator: | Kuan-Yu Hung, M.D. & Ph.D. | Nephrology Section, Department of Internal Medicine, National Taiwan University and College of Medicine |
Study Director: | Pau-Chung Chen, M.D. & Ph.D. | Institute of Occupational Medicine and Industrial Hygiene, College of Public Health, National Taiwan University |
Study ID Numbers: | P0702 |
Study First Received: | September 10, 2007 |
Last Updated: | September 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00527774 |
Health Authority: | Taiwan: Institutional Review Board |
Hepatitis C malnutrition-inflammation complex syndrome (MICS) dialysis mortality |
hospitalization health-related quality of life (HRQOL) peripheral arterial occlusive disease (PAOD) |
Arterial Occlusive Diseases Liver Diseases Metabolic Diseases Quality of Life Hepatitis, Viral, Human Insulin Inflammation Hepatitis |
Virus Diseases Hyperinsulinism Malnutrition Digestive System Diseases Hepatitis C Insulin Resistance Metabolic disorder Glucose Metabolism Disorders |
RNA Virus Infections Flaviviridae Infections |