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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

Tracking Information
First Submitted Date March 4, 2009
First Posted Date March 5, 2009
Last Update Posted Date June 16, 2020
Actual Study Start Date March 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 4, 2009)
  • inflammation and metabolic status [ Time Frame: first visit ]
  • Assessment of Fatty liver [ Time Frame: first visit ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fatty Liver in Inflammatory Bowel Disease (IBD) Patients
Official Title Prevalence of Fatty Liver in Inflammatory Bowel Disease (IBD) Patients and Mechanisms Related to Inflammation and Fatty Liver
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood count and biochemistry tests (such as: Liver and thyroid enzimes,cholesterol, immunology, glucose)
Sampling Method Non-Probability Sample
Study Population One hundred consecutive IBD patients treated at the Tel Aviv Sourasky Medical Center will be recruited.
Condition
  • Inflammatory Bowel Disease
  • Fatty Liver
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.

Study Groups/Cohorts cases
IBD patients above the age of 18 years old, suffering from the disease for at least one year.
Intervention: Other: clinical evaluation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: March 4, 2009)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date March 2011
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00855907
Other Study ID Numbers TASMC-09-NM-593-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Principle investigator - Gastroenterologist, Tel Aviv Sourasky medical center
Study Sponsor Tel-Aviv Sourasky Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Tel-Aviv Sourasky Medical Center
Verification Date June 2020