Metabolic SyndromeNCT01360268
The Metabolic Profile and Adipocytokine Alterations of Patients With HCV Infection Before and After HCV Therapy
An observational study of Metabolic Syndrome, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Rationale for this study: Correction of hypocholesteremia and insulin resistance after successful eradication of HCV by combination therapy of interferon and ribavirin has been shown in several studies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2011to Dec 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with chronic hepatitis C infections
Who may be able to join
- Aged 18 y/o or older
- Positive for the HCV antibody and HCV RNA detected
- Patients with abnormal liver function OR a liver biopsy specimen taken in the 6 months prior to study entry showing chronic hepatitis, or liver fibrosis, or liver cihhrosis
- Have not been previously treated with pegylated-interferon and ribavirin for HCV
- Genotype 1 or Genotype 2
Who cannot join
- Subjects with decompensated liver disease
- With human immunodeficiency virus
- With hepatitis B infection
- With hemochromatosis defined by a pre-existing diagnosis of hemochromatosis or a positive HFE gene mutation or recipients of solid organ transplants
- With clinically significant cardiac or cardiovascular abnormalities, organ grafts, systemic infections, clinically significant bleeding disorders, evidence of malignant neoplastic diseases
- Subjects who are on lipid-lowering medications
- Poorly controlled Diabetes (A1C > 9%) -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Metabolic Profile and Adipocytokine Alterations of Patients With HCV Infection Before and After HCV Therapy"
Rationale for this study:
Correction of hypocholesteremia and insulin resistance after successful eradication of HCV by combination therapy of interferon and ribavirin has been shown in several studies. The majority of these studies examined genotype 1 and some genotype 3 patients, but it is not clear if the same results can be achieved in other genotypes of HCV.
Read more
Moreover, clinical data of the relationships between different adipocytokines, metabolic profiles, and HCV and treatment is of value to further understand the mechanisms for HCVrelated metabolic alterations. The present proposal is designed to address the paradox of HCV-related metabolic alterations/adipocytokine alterations and to determine how BMI influences the HCV-related metabolic alteration/adipocytokine aterations by collecting and analyzing the samples from humans with HCV infection prior to and after combination of peginterferon alpha-2b plus ribavirin
For metabolic alternations:
Lipid profile: After treatment, responders in both genotype I and II will experience more increase of cholesterol levels and LDL levels than nonresponders/ relapseres. Insulin resistance: After treatment, responders with both genotype I and II will experience more decrease of HOMA-IR than nonresponders/ relapseres; higher percentage of responders will achieve HOMA-IR < 2 than nonresponders/ relapseres B. For adipocytokine alternation, this study is more of exploratory propose as there is still little well established consensus.
Read the detailed description
Subjects with chronic hepatitis C infections will be enrolled
Inclusion Criteria
- Aged 18 y/o or older
- Positive for the HCV antibody and HCV RNA detected
- Patients with abnormal liver function OR a liver biopsy specimen taken in the 6 months prior to study entry showing chronic hepatitis, or liver fibrosis, or liver cihhrosis
- Have not been previously treated with pegylated-interferon and ribavirin for HCV
- Genotype 1 or Genotype 2
Exclusion Criteria
- Subjects with decompensated liver disease
- With human immunodeficiency virus
- With hepatitis B infection
- With hemochromatosis defined by a pre-existing diagnosis of hemochromatosis or a positive HFE gene mutation or recipients of solid organ transplants
- With clinically significant cardiac or cardiovascular abnormalities, organ grafts, systemic infections, clinically significant bleeding disorders, evidence of malignant neoplastic diseases
- Subjects who are on lipid-lowering medications
- Poorly controlled Diabetes (A1C > 9%) The study will go through the CGMH IRB review and be posted into clinicaltrial.gov.
This is a single centre, prospective, open-label, single arm, interventional study.
- Conditions
- Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startJan 2011
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ming-Ling Chang, Principal investigator, CGMH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360268
- Sponsor's protocol ID
- Merck (MISP) # 38846
- Status last verified
- Feb 2011
- First submitted
- 24 May 2011
- Last updated
- 25 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Profile and Adipocytokine Alterations of Patients With HCV Infection Before and After HCV Therapy"
- ClinicalTrials.gov ID
- NCT01360268
- Acronym / sponsor ID
- Merck (MISP) # 38846
- Conditions
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Study completion
- Dec 2013 (estimated)
- First posted
- 25 May 2011 (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.
Rationale for this study:
Correction of hypocholesteremia and insulin resistance after successful eradication of HCV by combination therapy of interferon and ribavirin has been shown in several studies. The majority of these studies examined genotype 1 and some genotype 3 patients, but it is not clear if the same results can be achieved in other genotypes of HCV.
Moreover, clinical data of the relationships between different adipocytokines, metabolic profiles, and HCV and treatment is of value to further understand the mechanisms for HCVrelated metabolic alterations. The present proposal is designed to address the paradox of HCV-related metabolic alterations/adipocytokine alterations and to determine how BMI influences the HCV-related metabolic alteration/adipocytokine aterations by collecting and analyzing the samples from humans with HCV infection prior to and after combination of peginterferon alpha-2b plus ribavirin
For metabolic alternations:
Lipid profile: After treatment, responders in both genotype I and II will experience more increase of cholesterol levels and LDL levels than nonresponders/ relapseres. Insulin resistance: After treatment, responders with both genotype I and II will experience more decrease of HOMA-IR than nonresponders/ relapseres; higher percentage of responders will achieve HOMA-IR < 2 than nonresponders/ relapseres B. For adipocytokine alternation, this study is more of exploratory propose as there is still little well established consensus.
Detailed description
Subjects with chronic hepatitis C infections will be enrolled
Inclusion Criteria
- Aged 18 y/o or older
- Positive for the HCV antibody and HCV RNA detected
- Patients with abnormal liver function OR a liver biopsy specimen taken in the 6 months prior to study entry showing chronic hepatitis, or liver fibrosis, or liver cihhrosis
- Have not been previously treated with pegylated-interferon and ribavirin for HCV
- Genotype 1 or Genotype 2
Exclusion Criteria
- Subjects with decompensated liver disease
- With human immunodeficiency virus
- With hepatitis B infection
- With hemochromatosis defined by a pre-existing diagnosis of hemochromatosis or a positive HFE gene mutation or recipients of solid organ transplants
- With clinically significant cardiac or cardiovascular abnormalities, organ grafts, systemic infections, clinically significant bleeding disorders, evidence of malignant neoplastic diseases
- Subjects who are on lipid-lowering medications
- Poorly controlled Diabetes (A1C > 9%) The study will go through the CGMH IRB review and be posted into clinicaltrial.gov.
This is a single centre, prospective, open-label, single arm, interventional study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with chronic hepatitis C infections
Key inclusion criteria (5 listed)
- Aged 18 y/o or older
- Positive for the HCV antibody and HCV RNA detected
- Patients with abnormal liver function OR a liver biopsy specimen taken in the 6 months prior to study entry showing chronic hepatitis, or liver fibrosis, or liver cihhrosis
- Have not been previously treated with pegylated-interferon and ribavirin for HCV
- Genotype 1 or Genotype 2
Key exclusion criteria (7 listed)
- Subjects with decompensated liver disease
- With human immunodeficiency virus
- With hepatitis B infection
- With hemochromatosis defined by a pre-existing diagnosis of hemochromatosis or a positive HFE gene mutation or recipients of solid organ transplants
- With clinically significant cardiac or cardiovascular abnormalities, organ grafts, systemic infections, clinically significant bleeding disorders, evidence of malignant neoplastic diseases
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2011.
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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.
Ming-Ling Chang principal investigator
CGMH
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 Metabolic Syndrome, run by Chang Gung Memorial 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 May 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming-Ling Chang (88633281200 ext. 8101, mlchang8210@gmail.com), or a site near the patient. 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 25 May 2011; AzTrials last refreshed its copy on 8 Nov 2026.