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Fatty Liver in Inflammatory Bowel Disease (IBD) Patients
Recruitment status was: Not yet recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
| Inflammatory Bowel Disease Fatty Liver | Other: clinical evaluation |
| Study Type: | Observational |
| Study Design: | Time Perspective: Cross-Sectional |
| Official Title: | Prevalence of Fatty Liver in Inflammatory Bowel Disease (IBD) Patients and Mechanisms Related to Inflammation and Fatty Liver |
- inflammation and metabolic status [ Time Frame: first visit ]
- Assessment of Fatty liver [ Time Frame: first visit ]
Biospecimen Retention: Samples Without DNA
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
cases
IBD patients above the age of 18 years old, suffering from the disease for at least one year.
|
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. |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00855907
| Contact: Nitsan Maharshak, MD | 972-3-6974282 | nitsan_maharshak@walla.com |
| Israel | |
| Tel Aviv Sourasky Medical center | Not yet recruiting |
| Tel Aviv, Israel, 64239 | |
| Contact: Nitsan Maharshak, MD 972-3-6974282 nitsan_maharshak@walla.com | |
| Principal Investigator: Nitsan Maharshak, MD | |
More Information
| Responsible Party: | Principle investigator - Gastroenterologist, Tel Aviv Sourasky medical center |
| ClinicalTrials.gov Identifier: | NCT00855907 History of Changes |
| Other Study ID Numbers: |
TASMC-09-NM-593-CTIL |
| Study First Received: | March 4, 2009 |
| Last Updated: | March 4, 2009 |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
IBD inflammatory bowel disease fatty liver |
Additional relevant MeSH terms:
|
Intestinal Diseases Inflammatory Bowel Diseases Fatty Liver Gastrointestinal Diseases |
Digestive System Diseases Gastroenteritis Liver Diseases |
ClinicalTrials.gov processed this record on July 21, 2017