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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by St. Martin De Porress Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Taiwan University
Information provided by:
St. Martin De Porress Hospital
ClinicalTrials.gov Identifier:
NCT00527774
First received: September 10, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  Purpose

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: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Official Title: Impact of Hepatitis C Virus Infection on Insulin Resistance and Inflammatory Biomarkers in Patients With Maintenance Hemodialysis

Resource links provided by NLM:


Further study details as provided by St. Martin De Porress Hospital:

Estimated Enrollment: 200
Study Start Date: August 2007
Estimated Study Completion Date: September 2007
Groups/Cohorts
Case: A
HCV(+) maintenance hemodialysis patients
Control: B
HCV(-) maintenance hemodialysis patients

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527774

Contacts
Contact: Hung-Bin Tsai, M.D. 886-5-2756000 ext 3615 hbtsai@ms32.hinet.net

Locations
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.         
Sponsors and Collaborators
St. Martin De Porress Hospital
National Taiwan University
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00527774     History of Changes
Other Study ID Numbers: P0702
Study First Received: September 10, 2007
Last Updated: September 10, 2007
Health Authority: Taiwan: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 28, 2014