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Insulin Resistance Study (IR)

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Prashant Pandya, Kansas City Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00614757
First received: January 31, 2008
Last updated: October 25, 2012
Last verified: October 2012
History of Changes

January 31, 2008
October 25, 2012
May 2005
December 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00614757 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Insulin Resistance
  • Metabolic Syndrome x
  • Drug: N-acetylcysteine 20% 4ml
    N-acetylcysteine 20% 4ml
  • Drug: N-acetylcysteine 20% in 4 ml
    N-acetylcysteine 20% in 4 ml
  • No Intervention: 2
    One half of the patients will take not medication for 30 days and then have labs redrawn
  • Experimental: 1
    one half of the patients with insulin resistance will take 4ml of 20% N-acetylcysteine BID for 30 days
    Interventions:
    • Drug: N-acetylcysteine 20% 4ml
    • Drug: N-acetylcysteine 20% in 4 ml
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
121
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00614757
PKP0003, 00173
Yes
Prashant Pandya, Kansas City Veteran Affairs Medical Center
Midwest Biomedical Research Foundation
Not Provided
Principal Investigator: Prashant K Pandya, DO Kansas City VA Medical Center
Midwest Biomedical Research Foundation
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP