Fatty Liver in Inflammatory Bowel Disease (IBD) Patients
Recruitment status was Not yet recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | March 4, 2009 | ||||
| Last Updated Date | March 4, 2009 | ||||
| Start Date ICMJE | March 2009 | ||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Fatty Liver in Inflammatory Bowel Disease (IBD) Patients | ||||
| Official Title ICMJE | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | 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) |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | One hundred consecutive IBD patients treated at the Tel Aviv Sourasky Medical Center will be recruited. |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Group/Cohort (s) | cases
IBD patients above the age of 18 years old, suffering from the disease for at least one year.
Intervention: Other: clinical evaluation |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | March 2011 | ||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00855907 | ||||
| Other Study ID Numbers ICMJE | TASMC-09-NM-593-CTIL | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Principle investigator - Gastroenterologist, Tel Aviv Sourasky medical center | ||||
| Study Sponsor ICMJE | Tel-Aviv Sourasky Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Tel-Aviv Sourasky Medical Center | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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