Thyroid Dysfunction and Its Association With Metabolic Dysfunction-Associated Fatty Liver Disease

NCT06739330 | Recruiting

• 1 other identifier: 36264PR929/11/24
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the prevalence of thyroid dysfunction and its association with metabolic dysfunction-associated fatty liver disease.

Conditions

Thyroid Dysfunction; Metabolic Dysfunction-Associated Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Level of free triiodothyronine (FT3)

  Free triiodothyronine (FT3) will be measured using chemiluminescent immunoassay analysis.

  After the sample is taken (up to 5 minutes)

Secondary Outcomes (4)

• Level of free thyroxine (FT4)

  After the sample is taken (up to 5 minutes)

• Level of thyroid stimulating hormone

  After the sample is taken (up to 5 minutes)

• Relation between gender and thyroid function

  After the sample is taken (up to 5 minutes)

• Correlation between metabolic data and thyroid function tests

  After the sample is taken (up to 5 minutes)

Study Arms (2)

Study group

Patients with metabolic dysfunction-associated fatty liver disease (MAFLD)

Device: Fibroscan

Control group

Healthy control patients

Device: Fibroscan

Interventions

Fibroscan DEVICE

Fibroscan will be used to assess the stages of fibrosis and steatosis using Dimensional ultrasound TE (transient elastography). Dimensional ultrasound TE (transient elastography) will be used for staging liver fibrosis and steatosis by measuring the velocity of a low frequency (50 Hz) elastic shear wave propagating through the liver.

Control group; Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This cross-sectional case-control study will be carried out on 150 patients with metabolic dysfunction-associated fatty liver disease (MAFLD) at Tanta University Hospitals for a period from October 2024 to April 2025 after approval from the Institutional Ethical Committee.

You may qualify if:

• Age ≥ 18 years.
• Both sexes.
• Patients with metabolic dysfunction-associated fatty liver disease (MAFLD).

You may not qualify if:

• History of thyroid disease or treatment (e.g., thyroid nodules, thyroid cancer, hypothyroidism, and hyperthyroidism).
• Patients with alcoholic liver disease take more than 40g of alcohol (or four units) per day.
• Viral hepatitis.
• Pregnant women.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

Central Study Contacts

Shimaa A Meshaal, MD

CONTACT

00966559806580; shaimaa.meshaal2013@med.tanta.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 18, 2024
• Study Start: December 19, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)