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OpenTrials
Active, Not Recruiting

NCT Number: NCT01858012

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of california San Francisco

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderate alcohol cessation

Behavioral

patients will have moderate alcohol use discontinued for 6 weeks and have before and after alcohol cessation clinical and metabolic assessment and also patients with hepatitis C who have undergo therapy for hepatitis C may have repeat clinical and metabolic assessement

Other names: Hepatitis C therapy

Primary outcomes

  1. insulin resistance

    Time frame: baseline, 6 weeks and 18 months

    steady state plasma glucose level (mg/dL)

Secondary outcomes

  1. Insulin secretion

    Time frame: baseline, 6 weeks and 18 months

    insulin secretion rate area under the curve (pmol/min)

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2026
Study completion
2026
First posted
May 20, 2013
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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