NCT01858012

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jan 2008Dec 2026

Study Start

First participant enrolled

January 1, 2008

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2013

Completed
13.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

19 years

First QC Date

May 16, 2013

Last Update Submit

June 5, 2025

Conditions

Insulin Resistance

Keywords

insulin resistance

Outcome Measures

Primary Outcomes (1)

  • insulin resistance

    steady state plasma glucose level (mg/dL)

    baseline, 6 weeks and 18 months

Secondary Outcomes (1)

  • Insulin secretion

    baseline, 6 weeks and 18 months

Study Arms (2)

HCV infection

patients with hepatitis C infection

Behavioral: Moderate alcohol cessation

non-HCV infection

healthy controls

Behavioral: Moderate alcohol cessation

Interventions

Moderate alcohol cessationBEHAVIORAL

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
HCV infectionnon-HCV infection

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Latinos with and without HCV infection

You may qualify if:

  • 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
  • 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 may not qualify 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
  • Same as above, including subjects with HCV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of california San Francisco

San Francisco, California, 94110, United States

Location

Related Publications (10)

  • 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.

    PMID: 29220547RESULT

  • 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.

    PMID: 27007134RESULT

  • 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.

    PMID: 25156890RESULT

  • 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.

    PMID: 34773280RESULT

  • 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.

    PMID: 26554398RESULT

  • 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.

    PMID: 25196736RESULT

  • 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.

    PMID: 23086116RESULT

  • 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.

    PMID: 22399695RESULT

  • 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.

    PMID: 22676360RESULT

  • 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.

    PMID: 20578127RESULT

Biospecimen

Retention: SAMPLES WITH DNA

serum samples and liver tissue specimens for analysis

MeSH Terms

Conditions

Insulin Resistance

Interventions

Ethanol

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Mandana Khalili, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2013

First Posted

May 20, 2013

Study Start

January 1, 2008

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)