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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01360268
First received: May 24, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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
Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Metabolic Profile and Adipocytokine Alterations of Patients With HCV Infection Before and After HCV Therapy"

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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%) -
  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: 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
  More Information

No publications provided

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
Study First Received: May 24, 2011
Last Updated: May 24, 2011
Health Authority: Taiwan : Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014