Fatty Liver in Inflammatory Bowel Disease (IBD) Patients

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Fatty liver is known to be one of the most frequent liver pathologies in IBD patients (35-40%). Despite this fact, there are only few publications that evaluated the prevalence of fatty liver in IBD patients. Moreover, the pathogenesis of this phenomenon in IBD has not been widely investigated.

The paradox of lean patients and fatty liver can be explained by high use of steroids, by rapid weight loss, and by the abundance of TNFα cytokine in IBD patients that causes insulin resistance.

The aim of the study:

To evaluate the frequency of fatty liver in a cohort of IBD patients and to learn its risk factors.

Methods:

One hundred consecutive IBD patients treated at the Tel Aviv Sourasky Medical Center will be recruited.

Patients will fill up a questionnaire regarding their disease, demographic data, other co-morbidities and medications and risk factors for metabolic syndrome.

Each patient will undergo blood examinations in order to assess inflammation, and metabolic status. Fatty liver will be assessed by liver ultra-sonography.

Condition or disease	Intervention/treatment
Inflammatory Bowel Disease; Fatty Liver	Other: clinical evaluation

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Estimated Enrollment :	100 participants
Time Perspective:	Cross-Sectional
Official Title:	Prevalence of Fatty Liver in Inflammatory Bowel Disease (IBD) Patients and Mechanisms Related to Inflammation and Fatty Liver
Study Start Date :	March 2009
Estimated Primary Completion Date :	March 2010
Estimated Study Completion Date :	March 2011

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
cases; IBD patients above the age of 18 years old, suffering from the disease for at least one year.	Other: clinical evaluation; Patients will fill up a questionnaire regarding their disease, demographic data, other co-morbidities and medications and risk factors for metabolic syndrome. Each patient will undergo blood examinations in order to assess inflammation, and metabolic status. Fatty liver will be assessed by liver ultra-sonography.

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. inflammation and metabolic status [ Time Frame: first visit ]
2. Assessment of Fatty liver [ Time Frame: first visit ]

Biospecimen Retention:   Samples Without DNA

Blood count and biochemistry tests (such as: Liver and thyroid enzimes,cholesterol, immunology, glucose)

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

One hundred consecutive IBD patients treated at the Tel Aviv Sourasky Medical Center will be recruited.

Criteria

Inclusion Criteria:

• IBD patients above the age of 18 years old, suffering from the disease for at least one year.

Exclusion Criteria:

• Pregnant women,
• Patients suffering from ulcerative colitis after total colectomy,
• HIV patients,
• Patients suffering from other chronic liver disease,
• Patients suffering from cancer currently or in the past, OR
• Patients suffering from any other chronic severe diseases.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Nitsan Maharshak, MD	972-3-6974282	nitsan_maharshak@walla.com

Locations

Israel
Tel Aviv Sourasky Medical center	Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Nitsan Maharshak, MD 972-3-6974282 nitsan_maharshak@walla.com
Principal Investigator: Nitsan Maharshak, MD

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Principle investigator - Gastroenterologist, Tel Aviv Sourasky medical center
ClinicalTrials.gov Identifier:	NCT00855907 History of Changes
Other Study ID Numbers:	TASMC-09-NM-593-CTIL
First Posted:	March 5, 2009
Last Update Posted:	March 5, 2009
Last Verified:	March 2009

Keywords provided by Tel-Aviv Sourasky Medical Center:

IBD; inflammatory bowel disease; fatty liver

Additional relevant MeSH terms:

Intestinal Diseases; Inflammatory Bowel Diseases; Fatty Liver; Gastrointestinal Diseases	Digestive System Diseases; Gastroenteritis; Liver Diseases