Insulin Resistance in HCV Infection

Active, not recruiting

• Conditions: Insulin Resistance
• Interventions: Behavioral: Moderate alcohol cessation

• Registration Number: NCT01858012
• Lead Sponsor: University of California, San Francisco

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.

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.

Study Timeline

• Study Start: 2008-01-01
• Study First Submitted: 2013-05-16
• Study First Submitted QC: 2013-05-17
• Study First Posted: 2013-05-20
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-HCV infection	Moderate alcohol cessation	healthy controls
HCV infection	Moderate alcohol cessation	patients with hepatitis C infection

Primary Outcome Measures

Name	Time	Method
insulin resistance	baseline, 6 weeks and 18 months	steady state plasma glucose level (mg/dL)

Secondary Outcome Measures

Name	Time	Method
Insulin secretion	baseline, 6 weeks and 18 months	insulin secretion rate area under the curve (pmol/min)

Trial Locations

Locations (1)

University of california San Francisco; 🇺🇸 San Francisco, California, United States