Pancreatic Exocrine InsufficiencyNCT05804409
Screening for Pancreatic Exocrine Insufficieny in Metabolic Associated Fatty Liver Disease Patients
An observational study of Pancreatic Exocrine Insufficiency, run by Assiut University.
Trial summary
to investigate the frequency of PEI in MAFLD Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Exocrine Insufficiency
- What is being tested?
- FECAL ELASTASE
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Jul 2024
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: MAFLD is diagnosed in patients when they have both hepatic steatosis and any of the following three metabolic conditions: overweight/obesity, diabetes mellitus, or evidence of metabolic dysregulation (MD) in lean individuals.
Who may be able to join
- Age greater than 18 years, Patients diagnosed as MAFLD
Who cannot join
- Patients use steatogenic medications, hormone replacement therapy or herbal products, any alcohol intake.
- Patients with any history of pancreatic diseases like acute pancreatitis, chronic pancreatitis and pancreatic surgery.
- Patients with any malignancy.
Trial locations and contacts
No sites are listed yet.
About this study
to investigate the frequency of PEI in MAFLD
Read the detailed description
The growing epidemic of obesity is observed worldwide as lifestyles change to include higher caloric diets and decreasing physical activity.
With obesity; ectopic fat deposition in certain organs is accompanied by insulin resistance, hypertension and dyslipidemia; which in turn leads to metabolic syndrome As such, metabolic associated fatty liver disease (MAFLD), the hepatic manifestation of metabolic syndrome, has already become the most common cause of liver disease worldwide with a prevalence 25% Another important organ where ectopic fat deposition takes place is pancreas. Although hepatic fat is mainly intracellular and fatty pancreas is a consequence of adipocyte infiltration, evidence exists that fatty pancreas could be used as the initial indicator of ectopic fat deposition Recently, an advanced MRI technique - MRI-estimated proton density fat fraction (MRI-PDFF) - was shown to give reliable quantitative information of hepatic fat that is well correlated with liver biopsy The pancreas is composed of two glands - endocrine pancreas and exocrine pancreas- that are intimately mixed together into one organ Although exocrine pancreas comprise more than 95% of the pancreatic mass, to date there is no study conducted about the exocrine pancreas function and pancreatic fat in MAFLD patients The fecal pancreatic elastase (PE) test is a valuable indirect assay used in the evaluation of pancreatic exocrine function PE testing has become a standard diagnostic tool exhibiting good correlation with the results of direct functional tests as well as morphological changes in the pancreas discovered via imaging techniques In the last decade, significant number of studies were conducted on pancreatic exocrine insufficiency (PEI)
- Conditions
- Pancreatic Exocrine Insufficiency
- Being tested
- FECAL ELASTASE
- Keywords
- MAFLD
- Medical subject headings
- Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FECAL ELASTASEDiagnostic test
screening for pancreatic exocrine insufficiency in MAFLD patients
What is being measured
The primary outcome is the main question the study is designed to answer.
investigate the frequency of PEI in MAFLD
screening for PEI by fecal elastase test in MAFLD patients
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study startJun 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Exocrine InsufficiencyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Case only
- Time perspective
- Other
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Ahmed Mahmoud Hammam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804409
- Sponsor's protocol ID
- PEI in MAFLD
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boga S, Koksal AR, Sen I, Kurul Yeniay M, Yilmaz Ozguven MB, Serin E, Erturk SM, Alkim H, Alkim C. Liver and pancreas: 'Castor and Pollux' regarding the relationship between hepatic steatosis and pancreas exocrine insufficiency. Pancreatology. 2020 Jul;20(5):880-886. doi: 10.1016/j.pan.2020.04.020. Epub 2020 May 19.
PubMed 32475757
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Pancreatic Exocrine Insufficieny in Metabolic Associated Fatty Liver Disease Patients
- ClinicalTrials.gov ID
- NCT05804409
- Acronym / sponsor ID
- PEI in MAFLD
- Conditions
- Pancreatic Exocrine Insufficiency
- Keywords
- MAFLD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 7 Apr 2023 (actual)
- 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.
to investigate the frequency of PEI in MAFLD
Detailed description
The growing epidemic of obesity is observed worldwide as lifestyles change to include higher caloric diets and decreasing physical activity.
With obesity; ectopic fat deposition in certain organs is accompanied by insulin resistance, hypertension and dyslipidemia; which in turn leads to metabolic syndrome As such, metabolic associated fatty liver disease (MAFLD), the hepatic manifestation of metabolic syndrome, has already become the most common cause of liver disease worldwide with a prevalence 25% Another important organ where ectopic fat deposition takes place is pancreas. Although hepatic fat is mainly intracellular and fatty pancreas is a consequence of adipocyte infiltration, evidence exists that fatty pancreas could be used as the initial indicator of ectopic fat deposition Recently, an advanced MRI technique - MRI-estimated proton density fat fraction (MRI-PDFF) - was shown to give reliable quantitative information of hepatic fat that is well correlated with liver biopsy The pancreas is composed of two glands - endocrine pancreas and exocrine pancreas- that are intimately mixed together into one organ Although exocrine pancreas comprise more than 95% of the pancreatic mass, to date there is no study conducted about the exocrine pancreas function and pancreatic fat in MAFLD patients The fecal pancreatic elastase (PE) test is a valuable indirect assay used in the evaluation of pancreatic exocrine function PE testing has become a standard diagnostic tool exhibiting good correlation with the results of direct functional tests as well as morphological changes in the pancreas discovered via imaging techniques In the last decade, significant number of studies were conducted on pancreatic exocrine insufficiency (PEI)
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- MAFLD is diagnosed in patients when they have both hepatic steatosis and any of the following three metabolic conditions: overweight/obesity, diabetes mellitus, or evidence of metabolic dysregulation (MD) in lean individuals.
Key inclusion criteria (1 listed)
- Age greater than 18 years, Patients diagnosed as MAFLD
Key exclusion criteria (3 listed)
- Patients use steatogenic medications, hormone replacement therapy or herbal products, any alcohol intake.
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 |
|---|---|---|
| FECAL ELASTASEscreening for pancreatic exocrine insufficiency in MAFLD patients | Diagnostic test | – |
Primary outcome
investigate the frequency of PEI in MAFLD
Time frame: baseline
screening for PEI by fecal elastase test in MAFLD patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Background: PubMed 32475757Boga S, Koksal AR, Sen I, Kurul Yeniay M, Yilmaz Ozguven MB, Serin E, Erturk SM, Alkim H, Alkim C. Liver and pancreas: 'Castor and Pollux' regarding the relationship between hepatic steatosis and pancreas exocrine insufficiency. Pancreatology. 2020 Jul;20(5):880-886. doi: 10.1016/j.pan.2020.04.020. Epub 2020 May 19.
- screening for PEI in MAFLD patientsLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Exocrine Insufficiency, run by Assiut University.
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 3 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: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghada Ahmed, Master (01007267329, ahmedghada386@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
investigate the frequency of PEI in MAFLD (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05804409, which also lists 1 linked publication.
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 7 Apr 2023.