Insulin Resistance Study

Not Applicable

Suspended

• Conditions: Insulin Resistance; Metabolic Syndrome x
• Interventions: Drug: N-acetylcysteine 20% 4ml; Drug: N-acetylcysteine 20% in 4 ml

• Registration Number: NCT00614757
• Lead Sponsor: Midwest Biomedical Research Foundation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-01-31
• Study First Posted: 2008-02-13
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-25
• Last Update Posted: 2012-10-26
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	N-acetylcysteine 20% 4ml	one half of the patients with insulin resistance will take 4ml of 20% N-acetylcysteine BID for 30 days
1	N-acetylcysteine 20% in 4 ml	one half of the patients with insulin resistance will take 4ml of 20% N-acetylcysteine BID for 30 days

Primary Outcome Measures

Name	Time	Method
Those patients who are identified to have insulin resistance will be asked to participate in the treatment phase of the study	2 years

Secondary Outcome Measures

Name	Time	Method
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	2 years

Trial Locations

Locations (1)

Kansas City VA Medical Center; 🇺🇸 Kansas City, Missouri, United States