Association Between Non-alcoholic Fatty Liver Disease and Iron Status

NCT ID: NCT01307254

Last Updated: 2012-09-20

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

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-07-31

Brief Summary

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The investigators hypothesize that low iron storages protects from and down-grades non-alcoholic fatty liver disease.

The aim of the study is to show the association between the severity of Non-alcoholic fatty liver disease to low iron status.

Detailed Description

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Patients that will pass a CT scan that includes the abdomen will be asked to participate at our study. These patients will be divided into two groups - with and w/o fatty liver. The severity of fatty liver will be determined using the CT scan (as well as other parameters, such as the size of subcutaneous fat layer). Within 72 hours from the scan, a venous blood test will be taken from the enrolled patients (together with a BMI calculation and a blood pressure measurements). In the blood test we will examine liver functions, iron status etc.

This is a preliminary study that will aid in planning future strategies to treat or even prevent fatty liver (one of the epidemics of our century).

Conditions

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NAFLD - Non Alcoholic Fatty Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non alcoholic fatty liver disease

blood analysis

Intervention Type PROCEDURE

A single venous blood test will be taken - 4 tubes (hematology, clotting, chemistry, sedimentation rate)

control

blood analysis

Intervention Type PROCEDURE

A single venous blood test will be taken - 4 tubes (hematology, clotting, chemistry, sedimentation rate)

Interventions

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blood analysis

A single venous blood test will be taken - 4 tubes (hematology, clotting, chemistry, sedimentation rate)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age\>18
* BMI\>25

Exclusion Criteria

* pregnancy
* unable to sign an informed consent (legally)
* known solid/hematological malignancy
* hemoglobinopathy or myelodysplastic disease (not including G6PD deficiency)
* active or carrier of viral hepatitis
* treated a drug the cause fatty liver (eg. amiodarone, tetracyclin, HAART, steroid treatment \> 3 months)
* consumption of \> 120g ethanol per week
* primary liver disease (eg. glycogen storage disease)
* CRP\>20
* acute intoxication
* surgery in previous 7 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof Doron Zamir

UNKNOWN

Sponsor Role collaborator

Ornit Cohen

OTHER

Sponsor Role lead

Responsible Party

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Ornit Cohen

r&d unit

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Barzilai medical center

Ashkelon, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Albert Grinshpun

Role: CONTACT

Phone: 972-54-5615563

Email: [email protected]

Facility Contacts

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Albert Grinshpun

Role: primary

Other Identifiers

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BAFLA

Identifier Type: -

Identifier Source: org_study_id