Clinical trial NCT01360268: The Metabolic Profile and Adipocytokine Alterations of Patients With HCV Infection Before and After HCV Therapy
Official title: The Metabolic Profile and Adipocytokine Alterations of Patients With HCV Infection Before and After HCV Therapy"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Syndrome
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2011-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with chronic hepatitis C infections

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.

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 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%) -

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taiwan
country: Taiwan
facility: Ming-Ling Chang
Study officials:
affiliation: CGMH
name: Ming-Ling Chang
role: PRINCIPAL_INVESTIGATOR
References: