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Insulin Resistance Study

NCT ID: NCT00614757

Last Updated: 2012-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Insulin Resistance Metabolic Syndrome x

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2

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

Group Type NO_INTERVENTION

No interventions assigned to this group

1

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

Group Type EXPERIMENTAL

N-acetylcysteine 20% 4ml

Intervention Type DRUG

N-acetylcysteine 20% 4ml

N-acetylcysteine 20% in 4 ml

Intervention Type DRUG

N-acetylcysteine 20% in 4 ml

Interventions

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N-acetylcysteine 20% 4ml

N-acetylcysteine 20% 4ml

Intervention Type DRUG

N-acetylcysteine 20% in 4 ml

N-acetylcysteine 20% in 4 ml

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Midwest Biomedical Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Prashant Pandya

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prashant K Pandya, DO

Role: PRINCIPAL_INVESTIGATOR

Kansas City VA Medical Center

Locations

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Kansas City VA Medical Center

Kansas City, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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00173

Identifier Type: -

Identifier Source: secondary_id

PKP0003

Identifier Type: -

Identifier Source: org_study_id