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

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ClinicalTrials.gov Identifier: NCT01360268
Recruitment Status : Unknown
Verified February 2011 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : May 25, 2011
Last Update Posted : May 25, 2011
Sponsor:
Information provided by:
Chang Gung Memorial Hospital

Brief 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.


Condition or disease
Metabolic Syndrome

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.


Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Metabolic Profile and Adipocytokine Alterations of Patients With HCV Infection Before and After HCV Therapy"
Study Start Date : January 2011
Estimated Study Completion Date : December 2013

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U.S. FDA Resources





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:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects with chronic hepatitis C infections
Criteria

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%) -

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 ClinicalTrials.gov identifier (NCT number): NCT01360268


Contacts
Contact: Ming-Ling Chang 88633281200 ext 8101 mlchang8210@gmail.com

Locations
Taiwan
Ming-Ling Chang Recruiting
Taiwan, Taiwan, 33305
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Ming-Ling Chang CGMH

Responsible Party: Ming-Ling Chang/ M.D., Liver Research Unit,Division of Hepatology, Department of Hepatogastroenterology,Chang Gung memorial Hospital, Taoyuan, Taiwan
ClinicalTrials.gov Identifier: NCT01360268     History of Changes
Other Study ID Numbers: Merck (MISP) # 38846
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: May 25, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases