Status:
SUSPENDED
Insulin Resistance Study
Lead Sponsor:
Midwest Biomedical Research Foundation
Conditions:
Insulin Resistance
Metabolic Syndrome x
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00614757
Start Date
May 1 2005
End Date
December 1 2013
Last Update
October 26 2012
Active Locations (1)
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1
Kansas City VA Medical Center
Kansas City, Missouri, United States, 64128