NCT05804409

Brief Summary

to investigate the frequency of PEI in MAFLD

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

April 7, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

March 27, 2023

Last Update Submit

March 27, 2023

Conditions

Keywords

MAFLD

Outcome Measures

Primary Outcomes (1)

  • investigate the frequency of PEI in MAFLD

    screening for PEI by fecal elastase test in MAFLD patients

    baseline

Interventions

FECAL ELASTASEDIAGNOSTIC_TEST

screening for pancreatic exocrine insufficiency in MAFLD patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Age greater than 18 years, Patients diagnosed as MAFLD

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 32475757BACKGROUND

Related Links

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Central Study Contacts

Ghada Ahmed, Master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ghada Ahmed Mahmoud Hammam

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 7, 2023

Study Start

June 1, 2023

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

April 7, 2023

Record last verified: 2023-03