Status:
ACTIVE_NOT_RECRUITING
Insulin Resistance in HCV Infection
Lead Sponsor:
University of California, San Francisco
Conditions:
Insulin Resistance
Eligibility:
All Genders
18-60 years
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 resistanc...
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 resistanc...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT01858012
Start Date
January 1 2008
End Date
December 31 2026
Last Update
June 10 2025
Active Locations (1)
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1
University of california San Francisco
San Francisco, California, United States, 94110