Insulin Resistance in HCV Infection

University of California San Francisco (UCSF)

Status: Active, not recruiting

Conditions: Insulin Resistance

Treatments: Behavioral: Moderate alcohol cessation

Study type: Observational

Funder types: Other

Identifiers

NCT01858012

UCSF 10-00922

Details and patient eligibility

About

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. It is also hypothesized that moderate alcohol consumption impact insulin sensitivity and secretion with Latinos with or without HCV infection.

Full description

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

250 participants in 2 patient groups

HCV infection

Description:

patients with hepatitis C infection

Treatment:

Behavioral: Moderate alcohol cessation

non-HCV infection

Description:

healthy controls

Treatment:

Behavioral: Moderate alcohol cessation