Insulin Resistance Study

Original Study ID : PKP0003

Secondary ID : 00173

NCT ID : NCT00614757

Brief Title : Insulin Resistance Study

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

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.

Source : Kansas City Veteran Affairs Medical Center

Overall Status : Suspended

Start Date : May 2005

End Date : June 2008

Completion Date : June 2008

Official Title : N/A

Phase : Interventional

Study Design : Treatment, Randomized, Open Label, Parallel Assignment

Enrollment : 121

Verification Date : January 2008

First Received Date : January 31, 2008

Trial 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
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

Gender : Both

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : Accepts He

Facilities

Facility Name : Kansas City VA Medical Center

City : Kansas City

State : Missouri

Zip Code : 64128

Country : United States

OutComes

Primary OutComes

Measure : 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

Safety issue : No

Secondary OutComes

Measure : 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

Safety issue : No

Interventions

Type : Drug

Name : N-acetylcysteine 20% 4ml

Description : N-acetylcysteine 20% 4ml

Type : Drug

Name : N-acetylcysteine 20% in 4 ml

Description : N-acetylcysteine 20% in 4 ml

Clinical Trial Name - Insulin Resistance Study