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Fatty Liver in Inflammatory Bowel Disease (IBD) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00855907
Recruitment Status : Terminated (Lack of budget)
First Posted : March 5, 2009
Last Update Posted : June 16, 2020
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

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

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

Resource links provided by the National Library of Medicine


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.





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)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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


Locations
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Israel
Tel Aviv Sourasky Medical center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
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Responsible Party: Principle investigator - Gastroenterologist, Tel Aviv Sourasky medical center
ClinicalTrials.gov Identifier: NCT00855907    
Other Study ID Numbers: TASMC-09-NM-593-CTIL
First Posted: March 5, 2009    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Keywords provided by Tel-Aviv Sourasky Medical Center:
IBD
inflammatory bowel disease
fatty liver
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Fatty Liver
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Liver Diseases