Screening for Pancreatic Exocrine Insufficieny in Metabolic Associated Fatty Liver Disease Patients

NCT ID: NCT05804409

Last Updated: 2023-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-30

Study Completion Date

2024-07-31

Brief Summary

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to investigate the frequency of PEI in MAFLD

Detailed Description

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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

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Pancreatic Exocrine Insufficiency

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Interventions

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FECAL ELASTASE

screening for pancreatic exocrine insufficiency in MAFLD patients

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age greater than 18 years, Patients diagnosed as MAFLD

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Ahmed Mahmoud Hammam

Ghada Ahmed Mahmoud Hammam

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Ghada Ahmed, Master

Role: CONTACT

01007267329

References

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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.

Reference Type BACKGROUND
PMID: 32475757 (View on PubMed)

Related Links

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https://doi.org/10.1016/j.pan.2020.04.020

screening for PEI in MAFLD patients

Other Identifiers

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PEI in MAFLD

Identifier Type: -

Identifier Source: org_study_id

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