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

NCT01360268 | Unknown

• 1 other identifier: Merck (MISP) # 38846
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with chronic hepatitis C infections

You may qualify if:

• 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

You may not qualify if:

• 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%) -

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Ming-Ling Chang

Dawan, Taiwan, 33305, Taiwan

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ming-Ling Chang

  CGMH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Ling Chang

CONTACT

88633281200; mlchang8210@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: May 25, 2011
• Study Start: January 1, 2011
• Study Completion: December 1, 2013
• Last Updated: May 25, 2011

Record last verified: 2011-02

Locations

TW (1)