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Active, not recruitingNCT01858012Updated Jun 10, 2025

Insulin Resistance in HCV Infection

An observational study in Insulin Resistance, sponsored by University of California, San Francisco. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-10.

Sponsored by University of California, San Francisco · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years to 60 Years
Sex
All
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Study 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.

Read the detailed 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.

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Conditions studied

  • Insulin Resistance

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Keywords

  • insulin resistance
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In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's planned enrollment of 250 is above the median of 80 across 339 observational studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Latinos with and without HCV infection

Inclusion criteria

  • 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

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

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • HCV infection

    patients with hepatitis C infection

    Behavioral: Moderate alcohol cessation

  • non-HCV infection

    healthy controls

    Behavioral: Moderate alcohol cessation

Interventions

  • BehavioralModerate alcohol cessation

    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

    Also known as: Hepatitis C therapy

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What researchers measure

Primary outcomes

  1. insulin resistance

    steady state plasma glucose level (mg/dL)

    Time frame: baseline, 6 weeks and 18 months

Secondary outcomes

  1. Insulin secretion

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

    Time frame: baseline, 6 weeks and 18 months

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Study locations

1 site
  • University of california San Francisco
    San Francisco, California 94110, United States
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References and documents

Publications

  • Uribe LA, Bacchetti P, Gelman N, Burchard E, Fitch M, Hellerstein M, Khalili M. Impact of Moderate Alcohol Discontinuation on Insulin Action and Secretion in Latinos With and Without Hepatitis C. Alcohol Clin Exp Res. 2018 Mar;42(3):492-499. doi: 10.1111/acer.13576. Epub 2018 Feb 1. PubMed 29220547 ↗
  • Burman BE, Bacchetti P, Khalili M. Moderate Alcohol Use and Insulin Action in Chronic Hepatitis C Infection. Dig Dis Sci. 2016 Aug;61(8):2417-2425. doi: 10.1007/s10620-016-4119-0. Epub 2016 Mar 23. PubMed 27007134 ↗
  • Burman BE, Bacchetti P, Ayala CE, Gelman N, Melgar J, Khalili M. Liver inflammation is a risk factor for prediabetes in at-risk latinos with and without hepatitis C infection. Liver Int. 2015 Jan;35(1):101-7. doi: 10.1111/liv.12676. Epub 2014 Sep 20. PubMed 25156890 ↗
  • Kim RG, Kramer-Feldman J, Bacchetti P, Grimes B, Burchard E, Eng C, Hu D, Hellerstein M, Khalili M. Disentangling the impact of alcohol use and hepatitis C on insulin action in Latino individuals. Alcohol Clin Exp Res. 2022 Jan;46(1):87-99. doi: 10.1111/acer.14743. Epub 2021 Nov 23. PubMed 34773280 ↗
  • Gonzales CA, Bacchetti P, Khalili M. Impact of gender and menopausal status on metabolic parameters in chronic hepatitis C infection. J Viral Hepat. 2016 Mar;23(3):232-9. doi: 10.1111/jvh.12487. Epub 2015 Nov 10. PubMed 26554398 ↗
  • Shah SC, Kornak J, Khalili M. Depression is not associated with peripheral insulin resistance in patients with chronic hepatitis C infection. J Viral Hepat. 2015 Mar;22(3):272-80. doi: 10.1111/jvh.12306. Epub 2014 Sep 8. PubMed 25196736 ↗
  • Mukhtar NA, Bacchetti P, Ayala CE, Melgar J, Christensen S, Maher JJ, Khalili M. Insulin sensitivity and variability in hepatitis C virus infection using direct measurement. Dig Dis Sci. 2013 Apr;58(4):1141-8. doi: 10.1007/s10620-012-2438-3. Epub 2012 Oct 21. PubMed 23086116 ↗
  • Brandman D, Bacchetti P, Ayala CE, Maher JJ, Khalili M. Impact of insulin resistance on HCV treatment response and impact of HCV treatment on insulin sensitivity using direct measurements of insulin action. Diabetes Care. 2012 May;35(5):1090-4. doi: 10.2337/dc11-1837. Epub 2012 Mar 7. PubMed 22399695 ↗
  • Mukhtar NA, Ayala C, Maher JJ, Khalili M. Assessment of factors associated with pre-diabetes in HCV infection including direct and dynamic measurements of insulin action. J Viral Hepat. 2012 Jul;19(7):480-7. doi: 10.1111/j.1365-2893.2011.01568.x. Epub 2011 Dec 18. PubMed 22676360 ↗
  • Lam KD, Bacchetti P, Abbasi F, Ayala CE, Loeb SM, Shah V, Wen MJ, Reaven GM, Maher JJ, Khalili M. Comparison of surrogate and direct measurement of insulin resistance in chronic hepatitis C virus infection: impact of obesity and ethnicity. Hepatology. 2010 Jul;52(1):38-46. doi: 10.1002/hep.23670. PubMed 20578127 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01858012
Lead sponsor
University of California, San Francisco
Responsible party
Sponsor
First posted
May 20, 2013
Start date
Jan 1, 2008
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 10, 2025

Study contacts

Mandana Khalili, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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