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. Identifier: NCT00527774
Recruitment Status : Completed
First Posted : September 11, 2007
Last Update Posted : May 5, 2016
National Taiwan University
Information provided by (Responsible Party):
St. Martin De Porress Hospital

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.

Condition or disease
Hepatitis C Hemodialysis Quality of Life Mortality Hospitalization

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.

Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Hepatitis C Virus Infection on Insulin Resistance and Inflammatory Biomarkers in Patients With Maintenance Hemodialysis
Study Start Date : September 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

HCV(+) maintenance hemodialysis patients
HCV(-) maintenance hemodialysis patients

Biospecimen Retention:   Samples With DNA
Check HCV viral load and genotype in first month and sixth month

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A cross-sectional study was conducted in one regional teaching hospital (St. Martin De Porres Hospital) in Chiayi City in Taiwan and its medical alliance dialysis clinics during Sept. 2007 to March 2008.

Inclusion Criteria:

  • 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.

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00527774

Hemodialysis Center, St. Martin De Porres Hospital
Chiayi City, Taiwan, 60076
Sponsors and Collaborators
St. Martin De Porress Hospital
National Taiwan University
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

Responsible Party: St. Martin De Porress Hospital Identifier: NCT00527774     History of Changes
Other Study ID Numbers: P0702
First Posted: September 11, 2007    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: May 2016

Keywords provided by St. Martin De Porress Hospital:
Hepatitis C
malnutrition-inflammation complex syndrome (MICS)
health-related quality of life (HRQOL)
peripheral arterial occlusive disease (PAOD)

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Insulin Resistance
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Glucose Metabolism Disorders
Metabolic Diseases
Nutrition Disorders