Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
250 participants
OBSERVATIONAL
2008-01-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HCV infection
patients with hepatitis C infection
Moderate 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
non-HCV infection
healthy controls
Moderate 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
Interventions
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Moderate 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Mandana Khalili, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of california San Francisco
San Francisco, California, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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UCSF 10-00922
Identifier Type: -
Identifier Source: org_study_id
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