Insulin Resistance Study

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

Status

Suspended

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00614757

Acronym

Enrollment

121

Registered

2008-02-13

Start date

2005-05-31

Completion date

2013-12-31

Last updated

2012-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Metabolic Syndrome x

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.

Interventions

DRUGN-acetylcysteine 20% 4ml

N-acetylcysteine 20% 4ml

DRUGN-acetylcysteine 20% in 4 ml

N-acetylcysteine 20% in 4 ml

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026