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TerminatedNCT00855907Updated Jun 16, 2020

Fatty Liver in Inflammatory Bowel Disease (IBD) Patients

An observational study in Inflammatory Bowel Disease and Fatty Liver, sponsored by Tel-Aviv Sourasky Medical Center. Terminated at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by Tel-Aviv Sourasky Medical Center · Observational

Why this study was terminated
Lack of budget
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Inflammatory Bowel Disease
  • Fatty Liver

Keywords

  • IBD
  • inflammatory bowel disease
  • fatty liver
03

In context

Intestinal Diseases

963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.

This study's enrollment of 100 is below the median of 140 across 377 observational studies indexed under Intestinal Diseases.

Browse Intestinal Diseases studies →

Lead sponsor

Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
100 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • cases

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

    Other: clinical evaluation

Interventions

  • Otherclinical 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.

06

What researchers measure

Primary outcomes

  1. inflammation and metabolic status

    Time frame: first visit

  2. Assessment of Fatty liver

    Time frame: first visit

07

Study locations

1 site
  • Tel Aviv Sourasky Medical center
    Tel Aviv, 64239, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00855907
Lead sponsor
Tel-Aviv Sourasky Medical Center
First posted
Mar 5, 2009
Start date
Mar 2009
Primary completion
Mar 2010
Completion
Mar 2011
Last update
Jun 16, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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