Insulin Resistance Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate how often patients with hepatitis C infection have abnormalities of sugar and fat utilization. Additionally we would like to find out if these abnormalities of sugar and fat utilization are common in other liver diseases, or related to being overweight.

Official Title
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The Prevalence of Insulin Resistance and the Potential Modulation of Insulin Resistance by N-acetylcysteine (NAC) in Patients Chronically Infected by the Hepatitis C Virus

Conditions
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Insulin Resistance, Metabolic Syndrome x

Intervention / Treatment
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* Drug: N-acetylcysteine 20% 4ml
* Drug: N-acetylcysteine 20% in 4 ml


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to give written consent HCV RNA PCR positive for 6 months Normal Hgb, WBC,Neutrophils Platelets of >/= 65,000 Direct Bili, within 20% ULN Albumin >3 Serum Creatinine <20% ULN TSH WNL AFP </= 100 Exclusion Criteria: Women who are pregnant or breast-feeding No Thiazolidinedione, Metformin,unless required for the treatment of type II DM Hepatitis C of non-genotype 1,2,3 Any other cause for liver disease other than chronic hepatitis C Hemoglobinopathies Evidence of advanced liver disease Previous organ transplant Severe psychiatric disorder Significant cardiovascular dysfunction within the past 12 months Poorly controlled diabetes mellitus Immunologically mediated disease Any medical condition requiring chronic systemic administration of steroids Evidence of an active or suspected cancer Substance abuse at the time of the study Known HIV Irritability or unwillingness to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 2<br>One half of the patients will take not medication for 30 days and then have labs redrawn | |
| Experimental: 1<br>one half of the patients with insulin resistance will take 4ml of 20% N-acetylcysteine BID for 30 days | Drug: N-acetylcysteine 20% 4ml<br>* N-acetylcysteine 20% 4ml<br>Drug: N-acetylcysteine 20% in 4 ml<br>* N-acetylcysteine 20% in 4 ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Those patients who are identified to have insulin resistance will be asked to participate in the treatment phase of the study |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One half of patients with insulin resistance will undergo 30 day treatment with N-acetylcysteine to see if we can measure an improvement in fasting insulin and glucose levels |  | 2 years |