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

March 27, 2023 updated by: Ghada Ahmed Mahmoud Hammam, Assiut University
to investigate the frequency of PEI in MAFLD

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
investigate the frequency of PEI in MAFLD
Time Frame: baseline
screening for PEI by fecal elastase test in MAFLD patients
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEI in MAFLD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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