CClinicalTrials.gg
Sign In
Status unknownNCT01360268Updated May 25, 2011

The Metabolic Profile and Adipocytokine Alterations of Patients With HCV Infection Before and After HCV Therapy

An observational study in Metabolic Syndrome, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-05-25.

Sponsored by Chang Gung Memorial Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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. 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.

Read the detailed description

Subjects with chronic hepatitis C infections will be enrolled

Inclusion Criteria

  1. Aged 18 y/o or older
  2. Positive for the HCV antibody and HCV RNA detected
  3. 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
  4. Have not been previously treated with pegylated-interferon and ribavirin for HCV
  5. Genotype 1 or Genotype 2

Exclusion Criteria

  1. Subjects with decompensated liver disease
  2. With human immunodeficiency virus
  3. With hepatitis B infection
  4. With hemochromatosis defined by a pre-existing diagnosis of hemochromatosis or a positive HFE gene mutation or recipients of solid organ transplants
  5. With clinically significant cardiac or cardiovascular abnormalities, organ grafts, systemic infections, clinically significant bleeding disorders, evidence of malignant neoplastic diseases
  6. Subjects who are on lipid-lowering medications
  7. 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.

02

Conditions studied

  • Metabolic Syndrome

Browse trials for

03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 458 observational studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Subjects with chronic hepatitis C infections

Inclusion criteria

  1. Aged 18 y/o or older
  2. Positive for the HCV antibody and HCV RNA detected
  3. 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
  4. Have not been previously treated with pegylated-interferon and ribavirin for HCV
  5. Genotype 1 or Genotype 2

Exclusion criteria

Exclusion Criteria:

  1. Subjects with decompensated liver disease
  2. With human immunodeficiency virus
  3. With hepatitis B infection
  4. With hemochromatosis defined by a pre-existing diagnosis of hemochromatosis or a positive HFE gene mutation or recipients of solid organ transplants
  5. With clinically significant cardiac or cardiovascular abnormalities, organ grafts, systemic infections, clinically significant bleeding disorders, evidence of malignant neoplastic diseases
  6. Subjects who are on lipid-lowering medications
  7. Poorly controlled Diabetes (A1C > 9%) -
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
06

Study locations

1 of 1 sites recruiting
  • Ming-Ling Chang
    Taiwan, 33305, Taiwan
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01360268
Lead sponsor
Chang Gung Memorial Hospital
First posted
May 25, 2011
Start date
Jan 2011
Completion
Dec 2013 (estimated)
Last update
May 25, 2011

Study contacts

Ming-Ling Chang
Contact
mlchang8210@gmail.com
88633281200 ext. 8101
Ming-Ling Chang
principal investigator · CGMH

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Metabolic Syndrome→

Other studies from this sponsor

Chang Gung Memorial Hospital

Start the discussion