Back to resultsInsulin Resistance Study (IR)
Primary Purpose
Insulin Resistance, Metabolic Syndrome x
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
N-acetylcysteine 20% 4ml
N-acetylcysteine 20% in 4 ml
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance
Eligibility 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
Sites / Locations
- Kansas City VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
2
1
Arm Description
One half of the patients will take not medication for 30 days and then have labs redrawn
one half of the patients with insulin resistance will take 4ml of 20% N-acetylcysteine BID for 30 days
Outcomes
Primary Outcome Measures
Those patients who are identified to have insulin resistance will be asked to participate in the treatment phase of the study
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
Full Information
NCT ID
NCT00614757
First Posted
January 31, 2008
Last Updated
October 25, 2012
Sponsor
Midwest Biomedical Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00614757
Brief Title
Insulin Resistance Study
Acronym
IR
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Suspended
Study Start Date
May 2005 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Midwest Biomedical Research Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Metabolic Syndrome x
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
No Intervention
Arm Description
One half of the patients will take not medication for 30 days and then have labs redrawn
Arm Title
1
Arm Type
Experimental
Arm Description
one half of the patients with insulin resistance will take 4ml of 20% N-acetylcysteine BID for 30 days
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine 20% 4ml
Intervention Description
N-acetylcysteine 20% 4ml
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine 20% in 4 ml
Intervention Description
N-acetylcysteine 20% in 4 ml
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prashant K Pandya, DO
Organizational Affiliation
Kansas City VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kansas City VA Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Insulin Resistance Study
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