Inflammatory Bowel DiseaseNCT00855907
Fatty Liver in Inflammatory Bowel Disease (IBD) Patients
An observational study of Inflammatory Bowel Disease and Fatty Liver, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease, Fatty Liver
- What is being tested?
- clinical evaluation
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2009to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: One hundred consecutive IBD patients treated at the Tel Aviv Sourasky Medical Center will be recruited.
Who may be able to join
- IBD patients above the age of 18 years old, suffering from the disease for at least one year.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Fatty Liver in Inflammatory Bowel Disease (IBD) Patients and Mechanisms Related to Inflammation and Fatty Liver
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.
Read more
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
- Being tested
- clinical evaluation
- Keywords
- IBD, inflammatory bowel disease, fatty liver
- Medical subject headings
- Inflammatory Bowel Diseases, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical evaluationOther
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 group | Role | What they receive |
|---|---|---|
| cases | IBD patients above the age of 18 years old, suffering from the disease for at least one year. Receives: Other: clinical evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammation and metabolic status
Measured: first visit
Assessment of Fatty liver
Measured: first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010
- Study completionMar 2011
Why it stopped: Lack of budget
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855907
- Sponsor's protocol ID
- TASMC-09-NM-593-CTIL
- Status last verified
- Jun 2020
- First submitted
- 4 Mar 2009
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Fatty Liver in Inflammatory Bowel Disease (IBD) Patients and Mechanisms Related to Inflammation and Fatty Liver
- ClinicalTrials.gov ID
- NCT00855907
- Acronym / sponsor ID
- TASMC-09-NM-593-CTIL
- Conditions
- Inflammatory Bowel Disease, Fatty Liver
- Keywords
- IBD, inflammatory bowel disease, fatty liver
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of budget
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Mar 2009 (actual)
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 5 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cases | – | Other: clinical evaluationIBD patients above the age of 18 years old, suffering from the disease for at least one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred consecutive IBD patients treated at the Tel Aviv Sourasky Medical Center will be recruited.
Key inclusion criteria (1 listed)
- IBD patients above the age of 18 years old, suffering from the disease for at least one year.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical evaluationPatients 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. | Other | cases |
Primary outcome
inflammation and metabolic status
Time frame: first visit
Assessment of Fatty liver
Time frame: first visit
Results and safety
The study was stopped early (reason given: Lack of budget). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease and Fatty Liver, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of budget). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammation and metabolic status (time frame: first visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.