Title

Insulin Resistance Study
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
  • Phase

    N/A
  • Study Type

    Interventional
  • Status

    Suspended
  • Intervention/Treatment

    acetylcysteine ...
  • Study Participants

    121
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 Started
May 31
2005
Primary Completion
Dec 31
2013
Anticipated
Study Completion
Dec 31
2013
Anticipated
Last Update
Oct 26
2012
Estimate

Drug N-acetylcysteine 20% 4ml

N-acetylcysteine 20% 4ml

Drug N-acetylcysteine 20% in 4 ml

N-acetylcysteine 20% in 4 ml

2 No Intervention

One half of the patients will take not medication for 30 days and then have labs redrawn

1 Experimental

one half of the patients with insulin resistance will take 4ml of 20% N-acetylcysteine BID for 30 days

Criteria

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
No Results Posted