Insulin Resistance in HCV Infection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Insulin Resistance

Intervention / Treatment
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* Behavioral: Moderate alcohol cessation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCV infection<br>patients with hepatitis C infection | Behavioral: Moderate alcohol cessation<br>* 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<br>* Other names: Hepatitis C therapy;|
| non-HCV infection<br>healthy controls | Behavioral: Moderate alcohol cessation<br>* 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<br>* Other names: Hepatitis C therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin resistance | steady state plasma glucose level (mg/dL) | baseline, 6 weeks and 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin secretion | insulin secretion rate area under the curve (pmol/min) | baseline, 6 weeks and 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin resistance