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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
  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: 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:

U.S. FDA Resources

Further study details as provided by Midwest Biomedical Research Foundation:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 31, 2008
Last Updated: October 25, 2012
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on May 23, 2013