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Insulin Resistance Study (IR)

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00614757
First Posted: February 13, 2008
Last Update Posted: October 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prashant Pandya, Kansas City Veteran Affairs Medical Center
  Purpose
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.

Condition Intervention
Insulin Resistance Metabolic Syndrome x Drug: N-acetylcysteine 20% 4ml Drug: N-acetylcysteine 20% in 4 ml

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Prashant Pandya, Kansas City Veteran Affairs Medical Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 121
Study Start Date: May 2005
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: N-acetylcysteine 20% 4ml
N-acetylcysteine 20% 4ml
Drug: N-acetylcysteine 20% in 4 ml
N-acetylcysteine 20% in 4 ml

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00614757


Locations
United States, Missouri
Kansas City VA Medical Center
Kansas City, Missouri, United States, 64128
Sponsors and Collaborators
Midwest Biomedical Research Foundation
Investigators
Principal Investigator: Prashant K Pandya, DO Kansas City VA Medical Center
  More Information

Responsible Party: Prashant Pandya, Principal Investigator, Kansas City Veteran Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00614757     History of Changes
Other Study ID Numbers: PKP0003
00173
First Submitted: January 31, 2008
First Posted: February 13, 2008
Last Update Posted: October 26, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Acetylcysteine
N-monoacetylcystine
Hypoglycemic Agents
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antidotes