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

(BAFLA- Barzilai Fatty Liver and Iron Metabolism Study)

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.

Study Overview

• Status: Unknown
• Conditions: NAFLD - Non Alcoholic Fatty Liver Disease
• Intervention / Treatment: Procedure: blood analysis

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).

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• Israel
  • Ashkelon, Israel, 78278
    • Recruiting
    • Barzilai Medical Center
    • Contact: Albert Grinshpun; Phone Number: 972-54-5615563; Email: albert.grinshpun@mail.huji.ac.il
    • Principal Investigator: Zamir Doron, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control	Procedure: blood analysis; A single venous blood test will be taken - 4 tubes (hematology, clotting, chemistry, sedimentation rate)
Non alcoholic fatty liver disease	Procedure: blood analysis; A single venous blood test will be taken - 4 tubes (hematology, clotting, chemistry, sedimentation rate)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
grade of fatty liver disease	1 year

Collaborators and Investigators

• Sponsor: Ornit Cohen
• Collaborators: Prof Doron Zamir

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): January 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: January 5, 2011
• First Submitted That Met QC Criteria: March 1, 2011
• First Posted (Estimate): March 2, 2011

Study Record Updates

• Last Update Posted (Estimate): September 20, 2012
• Last Update Submitted That Met QC Criteria: September 19, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: BAFLA