Fatty Liver in Inflammatory Bowel Disease (IBD) Patients

NCT00855907 | Terminated

• 1 other identifier: TASMC-09-NM-593-CTIL
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease; Fatty Liver

Keywords

IBD; inflammatory bowel disease; fatty liver

Outcome Measures

Primary Outcomes (2)

• inflammation and metabolic status

  first visit

• Assessment of Fatty liver

  first visit

Study Arms (1)

cases

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

Other: clinical evaluation

Interventions

clinical evaluation OTHER

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.

cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical center

Tel Aviv, 64239, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Fatty Liver

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 4, 2009
• First Posted: March 5, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2011
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

IL (1)