Insulin Resistance Study

Insulin Resistance Clinical Trial

— 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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00614757
• Other study ID #: PKP0003
• Secondary ID: 00173
• Status: Suspended
• Phase: N/A
• First received: January 31, 2008
• Last updated: October 25, 2012
• Start date: May 2005
• Est. completion date: December 2013

Study information

• Verified date: October 2012
• Source: Midwest Biomedical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 121
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome X

Intervention

Drug:
• N-acetylcysteine 20% 4ml
N-acetylcysteine 20% 4ml
• N-acetylcysteine 20% in 4 ml
N-acetylcysteine 20% in 4 ml

Locations

Country	Name	City	State
United States	Kansas City VA Medical Center	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Midwest Biomedical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Those patients who are identified to have insulin resistance will be asked to participate in the treatment phase of the study		2 years	No
Secondary	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	No