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Association Between Non-alcoholic Fatty Liver Disease and Iron Status (BAFLA)

This study is currently recruiting participants.
Verified September 2012 by Barzilai Medical Center
Sponsor:
Collaborator:
Prof Doron Zamir
Information provided by (Responsible Party):
Ornit Cohen, Barzilai Medical Center
ClinicalTrials.gov Identifier:
NCT01307254
First received: January 5, 2011
Last updated: September 19, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
NAFLD - Non Alcoholic Fatty Liver Disease
 Procedure: blood analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: (BAFLA- Barzilai Fatty Liver and Iron Metabolism Study)

Resource links provided by NLM:

MedlinePlus related topics: Iron Liver Diseases
U.S. FDA Resources

Further study details as provided by Barzilai Medical Center:

Primary Outcome Measures:
  • grade of fatty liver disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Non alcoholic fatty liver disease Procedure: blood analysis
A single venous blood test will be taken - 4 tubes (hematology, clotting, chemistry, sedimentation rate)
control Procedure: blood analysis
A single venous blood test will be taken - 4 tubes (hematology, clotting, chemistry, sedimentation rate)

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients that will pass a CT scan at our institution. The scan must include the abdomen, with or without any contrast material.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307254

Contacts
Contact: Albert Grinshpun 972-54-5615563 albert.grinshpun@mail.huji.ac.il

Locations
Israel
Barzilai medical center Recruiting
Ashkelon, Israel, 78278
Contact: Albert Grinshpun     972-54-5615563     albert.grinshpun@mail.huji.ac.il    
Principal Investigator: Zamir Doron, Prof            
Sponsors and Collaborators
Ornit Cohen
Prof Doron Zamir
  More Information

No publications provided

Responsible Party: Ornit Cohen, r&d unit, Barzilai Medical Center
ClinicalTrials.gov Identifier: NCT01307254     History of Changes
Other Study ID Numbers: BAFLA
Study First Received: January 5, 2011
Last Updated: September 19, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013