Insulin Resistance Study

Midwest Biomedical Research Foundation121 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

121

Conditions

Insulin Resistance Metabolic Syndrome x

Interventions

N-acetylcysteine 20% 4mlDRUG

N-acetylcysteine 20% 4ml

N-acetylcysteine 20% in 4 mlDRUG

N-acetylcysteine 20% in 4 ml

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Kansas City VA Medical Center

Kansas City, Missouri, United States

Outcomes

Primary Outcomes

Those patients who are identified to have insulin resistance will be asked to participate in the treatment phase of the study

Time frame: 2 years

Secondary Outcomes

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

Time frame: 2 years

Data from ClinicalTrials.gov

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