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

Pancreatic Exocrine Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05804409
• Other study ID #: PEI in MAFLD
• Status: Not yet recruiting
• Start date: June 2023
• Est. completion date: July 2024

Study information

• Verified date: March 2023
• Source: Assiut University
• Contact: Ghada Ahmed, Master
• Phone: 01007267329
• Email: ahmedghada386[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

to investigate the frequency of PEI in MAFLD

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exocrine Pancreatic Insufficiency
• Fatty Liver
• Liver Diseases
• Pancreatic Exocrine Insufficiency

Intervention

Diagnostic Test:
• FECAL ELASTASE
screening for pancreatic exocrine insufficiency in MAFLD patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	investigate the frequency of PEI in MAFLD	screening for PEI by fecal elastase test in MAFLD patients	baseline

External Links

•   screening for PEI in MAFLD patients