Fatty Liver in Inflammatory Bowel Disease (IBD) Patients

Inflammatory Bowel Disease Clinical Trial

Official title:

Prevalence of Fatty Liver in Inflammatory Bowel Disease (IBD) Patients and Mechanisms Related to Inflammation and Fatty Liver

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00855907
• Other study ID #: TASMC-09-NM-593-CTIL
• Status: Terminated
• Start date: March 2009
• Est. completion date: March 2011

Study information

• Verified date: June 2020
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: March 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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.

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammation and metabolic status		first visit
Primary	Assessment of Fatty liver		first visit