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

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

Study Overview

• Status: Recruiting
• Conditions: Thyroid Dysfunction; Metabolic Dysfunction-Associated Fatty Liver Disease
• Intervention / Treatment: Device: Fibroscan

Detailed Description

One of the most common causes of chronic liver diseases worldwide is metabolic dysfunction-associated fatty liver disease (MAFLD), which affects about 30% of adults. Thyroid hormones are critical in maintaining metabolic homeostasis throughout life and are intimately linked to the liver.

Dysfunctions of the thyroid gland have been implicated as one of the most important risk factors of MAFLD due to its important role in the hepatic synthesis of fatty acid and cholesterol. Maintaining liver metabolism requires thyroid function to be normal, while thyroid disorders may lead to liver disease progression.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Shimaa A Meshaal, MD; Phone Number: 00966559806580; Email: shaimaa.meshaal2013@med.tanta.edu.eg

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Contact: Shimaa A Meshaal, MD; Phone Number: 00966559806580; Email: shaimaa.meshaal2013@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Patients with metabolic dysfunction-associated fatty liver disease (MAFLD)	Device: Fibroscan; 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; Healthy control patients	Device: Fibroscan; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of free thyroxine (FT4)	Free thyroxine (FT4) will be measured using chemiluminescent immunoassay analysis.	After the sample is taken (up to 5 minutes)
Level of thyroid stimulating hormone	Thyroid stimulating hormone will be measured using chemiluminescent immunoassay analysis.	After the sample is taken (up to 5 minutes)
Relation between gender and thyroid function	Relation between gender and thyroid function will be assessed.	After the sample is taken (up to 5 minutes)
Correlation between metabolic data and thyroid function tests	Correlation between metabolic data and thyroid function tests will be assessed.	After the sample is taken (up to 5 minutes)

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Digestive System Diseases; Thyroid Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 36264PR929/11/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No