Insulin Resistance Study (IR)

Midwest Biomedical Research Foundation

Status: Suspended

Conditions: Metabolic Syndrome x; Insulin Resistance

Treatments: Drug: N-acetylcysteine 20% in 4 ml; Drug: N-acetylcysteine 20% 4ml

Study type: Interventional

Funder types: Other

Identifiers

NCT00614757

PKP0003

00173

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 2 patient groups

2

No Intervention group

Description:

One half of the patients will take not medication for 30 days and then have labs redrawn

1

Experimental group

Description:

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

Treatment:

Drug: N-acetylcysteine 20% in 4 ml

Drug: N-acetylcysteine 20% 4ml