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Summary

for people ages 18–60 (full criteria)
healthy people welcome
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

Impact of Hepatitis C on Insulin Sensitivity and Insulin Secretion in Latinos

Details

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.

Keywords

Insulin Resistance Insulin, Globin Zinc Insulin

Eligibility

You can join if…

Open to people ages 18–60

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

You CAN'T join if...

  • 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

Locations

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT01858012
Lead Scientist
Mandana Khalili
Study Type
Observational
Last Updated
July 2016