Hepatitis CNCT00527774
Effect of HCV Infection on Insulin Resistance and Malnutrition-inflammation Complex Syndrome in Regular Hemodialysis Patients
An observational study of Hepatitis C and Hemodialysis, run by St. Martin De Porress Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Hemodialysis, Quality of Life
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2007to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Hemodialysis Center, St. Martin De Porres Hospital
Chiayi City, 60076
About this study
Official title: Impact of Hepatitis C Virus Infection on Insulin Resistance and Inflammatory Biomarkers in Patients With Maintenance Hemodialysis
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.
Read the 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
- Keywords
- Hepatitis C, malnutrition-inflammation complex syndrome (MICS), dialysis, mortality, hospitalization, health-related quality of life (HRQOL), peripheral arterial occlusive disease (PAOD)
- Medical subject headings
- Hepatitis C, Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | HCV(+) maintenance hemodialysis patients | |
| B | HCV(-) maintenance hemodialysis patients |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionFeb 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Martin De Porress Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University
- Responsible party
- Sponsor
- Investigators
- Chung-Jing Wang, M.D., Study chair, St. Martin De Porres HospitalKuan-Yu Hung, M.D. & Ph.D., Principal investigator, Nephrology Section, Department of Internal Medicine, National Taiwan University and College of MedicinePau-Chung Chen, M.D. & Ph.D., Study director, Institute of Occupational Medicine and Industrial Hygiene, College of Public Health, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527774
- Sponsor's protocol ID
- P0702
- Status last verified
- May 2016
- First submitted
- 10 Sep 2007
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hepatitis C Virus Infection on Insulin Resistance and Inflammatory Biomarkers in Patients With Maintenance Hemodialysis
- ClinicalTrials.gov ID
- NCT00527774
- Acronym / sponsor ID
- P0702
- Conditions
- Hepatitis C, Hemodialysis, Quality of Life, Mortality, Hospitalization
- Keywords
- Hepatitis C, malnutrition-inflammation complex syndrome (MICS), dialysis, mortality, hospitalization, health-related quality of life (HRQOL), peripheral arterial occlusive disease (PAOD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- St. Martin De Porress HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University
- Study start
- Sep 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 11 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –HCV(+) maintenance hemodialysis patients |
| B | – | –HCV(-) maintenance hemodialysis patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung-Jing Wang, M.D. study chair
St. Martin De Porres Hospital
Kuan-Yu Hung, M.D. & Ph.D. principal investigator
Nephrology Section, Department of Internal Medicine, National Taiwan University and College of Medicine
Pau-Chung Chen, M.D. & Ph.D. study director
Institute of Occupational Medicine and Industrial Hygiene, College of Public Health, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and Hemodialysis, run by St. Martin De Porress Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.