Effect of HCV Infection on Insulin Resistance and Malnutrition-inflammation Complex Syndrome in Regular Hemodialysis Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00527774|
Recruitment Status : Completed
First Posted : September 11, 2007
Last Update Posted : May 5, 2016
|Condition or disease|
|Hepatitis C Hemodialysis Quality of Life Mortality Hospitalization|
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.
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||Impact of Hepatitis C Virus Infection on Insulin Resistance and Inflammatory Biomarkers in Patients With Maintenance Hemodialysis|
|Study Start Date :||September 2007|
|Primary Completion Date :||February 2008|
|Study Completion Date :||March 2008|
HCV(+) maintenance hemodialysis patients
HCV(-) maintenance hemodialysis patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527774
|Hemodialysis Center, St. Martin De Porres Hospital|
|Chiayi City, Taiwan, 60076|
|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|