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Fatty Liver in Inflammatory Bowel Disease (IBD) Patients

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ClinicalTrials.gov Identifier: NCT00855907
Recruitment Status : Unknown
Verified March 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 5, 2009
Last Update Posted : March 5, 2009
Sponsor:
Information provided by:

Study Description
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

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855907


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

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    Key Record Dates
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