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Fatty Liver in Inflammatory Bowel Disease (IBD) Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00855907
First received: March 4, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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 Intervention
Inflammatory Bowel Disease
Fatty Liver
 Other: clinical evaluation

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Prevalence of Fatty Liver in Inflammatory Bowel Disease (IBD) Patients and Mechanisms Related to Inflammation and Fatty Liver

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • inflammation and metabolic status [ Time Frame: first visit ] [ Designated as safety issue: No ]
  • Assessment of Fatty liver [ Time Frame: first visit ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
Blood count and biochemistry tests (such as: Liver and thyroid enzimes,cholesterol, immunology, glucose)

Estimated Enrollment: 100
Study Start Date: March 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: March 4, 2009
Last Updated: March 4, 2009
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on September 28, 2016