Insulin Resistance in HCV Infection

The study hypothesis is that the means by which HCV induces glucose intolerance is through
impairment of B-cell function and compensatory hyperinsulinemia in predisposed Latinos with
insulin resistance and that HCV eradication improves these abnormalities. This study
addresses changes in the metabolic parameters over time. In addition, it is hypothesized that
moderate alcohol consumption impacts insulin resistance and secretion and 30 patients with or
without HCV who drink alcohol moderately will have discontinuation of alcohol use for 6 weeks
and have metabolic testing before and after alcohol discontinuation.

Inclusion criteria for HCV participants:

- Male or female patients between 18 and 60 years of age

- Body mass index (BMI) > 20 Kg/m2

- Serologic evidence of hepatitis C infection by anti-HCV antibody

- Detectable plasma HCV-RNA

- Compensated liver disease with the following minimum biochemical parameters:
prothrombin time < 2 seconds prolonged compared to control and bilirubin < 3 mg/dL

- Willingness to provide informed consent

Inclusion criteria for healthy Latino volunteers (without HCV infection):

-Same inclusion criteria as above except no evidence of HCV infection (anti-HCV antibody
negative)

Inclusion criteria for participation in 6-week alcohol abstinence follow-up testing:

-Latinos who are moderate1 alcohol drinkers (1NIAAA definition: female: no more than 3
drinks on any day & no more than 7 drinks per week; male: no more than 4 drinks on any day
and no more than 14 drinks per week).

Steady-State Plasma Glucose < 180 mg/dL

Exclusion criteria:

- Hepatitis B or HIV infection

- Subjects with liver disease other than that caused by HCV

- Known history of diabetes, or fasting plasma glucose concentration >126 mg/dl

- Known history of cirrhosis of the liver, as well as individuals with decompensated
liver disease such as those with ascites, variceal bleeding, and encephalopathy

- Known history of pancreatitis

- Prior or current treatment for HCV

- Heavy alcohol use (>80 g/d)

- Subjects of lipid lowering agents, steroid/ anabolic therapy

- Significant medical illness that would interfere with the completion of the study

Exclusion criteria for healthy (non HCV) Latino volunteers:

-Same as above, including subjects with HCV infection