Association Between Overt and Sub-clinical Primary Hypothyroidism and Metabolic Dysfunction-Associated Steatoic Liver Disease in Non-Diabetic Patients

Association Between Overt and Sub-clinical Primary Hypothyroidism and Metabolic Dysfunction-Associated Steatoic Liver Disease (MASLD) in Non-Diabetic Patients

This study aims to estimate the prevalence of Metabolic dysfunction - associated Steatoic liver disease (MASLD) among adults with primary hypothyroidism (overt or sub-clinical 1ry hypothyroidism) and prevalence of MASLD in Hashimoto-thyroiditis vs Euthyroid controls in non-diabetic patients.

Study Overview

• Status: Recruiting
• Conditions: Primary Hypothyroidism; Non-Diabetic Patients; Overt; Sub-clinical; Metabolic Dysfunction-Associated Steatoic Liver Disease
• Intervention / Treatment: Diagnostic test: FibroScan; Diagnostic test: Thyroid Function Assessment

Detailed Description

Metabolic dysfunction - associated Steatoic liver disease (MASLD), previously known as non-alcoholic fatty liver disease (NAFLD), has become the leading cause of chronic liver disease globally.

Metabolic dysfunction -associated Steatoic liver disease (MASLD) is the prevailing chronic hepatic disorder, where it is characterized by hepatic steatosis affecting more than 5% of hepatocyte in absence of excessive alcohol consumption (> 30g/ day for men and >20g/day for women), or other underlying chronic liver diseases, and it is commonly associated metabolic risk factors such as obesity and type 2 diabetes.

Hypothyroidism is characterized by the reduction or absence of thyroid hormones.it can be manifest at birth as (congenital) or develop later (acquired). The most common cause of hypothyroidism is primary hypothyroidism due to dysfunction of the thyroid gland.

Overt hypothyroidism is a prevalent clinical thyroid disorder characterized by elevated serum thyrotropin (TSH) levels as well as reduced free thyroxine (FT4) levels.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Islam K Fathy, MSc; Phone Number: 00201011456295; Email: islam.ali2@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag Governorate
    • Sohag, Sohag Governorate, Egypt, 82511
      • Recruiting
      • Sohag University
      • Contact: Islam K Fathy, MSc; Phone Number: 00201011456295; Email: islam.ali2@med.sohag.edu.eg
      • Sub-Investigator: Nayel A Zaki, MD
      • Sub-Investigator: Amal K Ahmed, MD
      • Sub-Investigator: Ahmed N Nour Eldin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The patient population for the trial will be derived from Sohag University hospital/ Endocrine or Hepatology outpatient clinic.

The study protocol will be approved by the Ethics Committee of Sohag Faculty of Medicine.

Description

Inclusion Criteria:

• Patients aged ≥18years old who will be:
• Diagnosed with primary hypothyroidism (overt or sub clinical hypothyroidism) within 3 months with or without levothyroxine treatment.
• Patients with positive antibody (positive TPO antibody or positive Thyroglobin antibody) irrespective of thyroid status
• Metabolic dysfunction-associated steatotic liver disease (MASLD) assessment by ultrasound and Fibro-scan.

Exclusion Criteria:

• Diabetic patients according to American Diabetes Association (ADA) Criteria.
• Excessive Alcohol consumption (> 30 gm/ day in men, 20 gm /day in women.
• Body mass index (BMI) index >40 kg/m2
• Other causes of chronic hepatic steatosis [e.g., positive hepatitis B virus (HBV), positive hepatitis C virus (HCV)), autoimmune disease, Wilson disease, drugs].
• Patients use of drugs known to cause hepatic steatosis (e.g., amiodarone, valproate, tamoxifen, methotrexate, steroids).
• Treatment with drugs that influence liver fat, as thiazolidinediones, α-glucosidase inhibitors, sodium-glucose -transporter 2 (SGLT2) inhibitors or any glucagon-like peptide-1 receptor agonists during the previous 3 months.
• Detection of biliary duct obstruction based on imaging studies.
• Evidence of cirrhosis [on basis of ultrasonography and magnetic resonance imaging (MRI )] or hepatocellular carcinoma [evidence on triphasic Computed Tomography (CT) or MRI].
• Presence of any systemic disease that commonly cause liver disease.
• Severe hepatic injury and/or significant abnormal liver function defined as aspartate aminotransferase >5× upper limit of normal (ULN) and/or alanine aminotransferase >5× ULN or elevated total bilirubin > 2 mg/dl.
• Pregnant women.
• Patients with active malignancy.
• History of bariatric surgery or ongoing weight-loss diet (hypocaloric diet) or use of weight-loss agents unless the diet or treatment has been stopped at least 3 months before screening and that the patient has had a stable body weight (+/- 3 kg) during the 3 months before screening.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Euthyroid group; Participants whom thyroid function tests are normal and screened for Metabolic dysfunction - associated Steatoic liver disease (MASLD).	Diagnostic test: FibroScan; Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).; Diagnostic test: Thyroid Function Assessment; Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).
Case group-1; Patients with overt primary hypothyroidism (High TSH and low FT4, FT3) that screening for Metabolic dysfunction - associated Steatoic liver disease (MASLD).	Diagnostic test: FibroScan; Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).; Diagnostic test: Thyroid Function Assessment; Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).
Case group-2; Patients with sub clinical hypothyroidism (High TSH and normal FT4, FT3) and screened for Metabolic dysfunction - associated Steatoic liver disease (MASLD).	Diagnostic test: FibroScan; Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).; Diagnostic test: Thyroid Function Assessment; Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).
Case group-3; Patients with positive thyroid auto-antibodies (normal TSH, normal FT4, normal FT3, Positive TPo antibody or positive thyroglobin antibody) screened for Metabolic dysfunction - associated Steatoic liver disease (MASLD).	Diagnostic test: FibroScan; Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).; Diagnostic test: Thyroid Function Assessment; Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the prevalence of metabolic dysfunction-associated steatotic liver disease	Prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) diagnosed by abdominal ultrasonography/FibroScan among adults with primary hypothyroidism will be assessed.	3 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between severity of primary hypothyroidism and the degree of hepatic steatosis	Correlation between severity of primary hypothyroidism [measured by Thyroid-stimulating hormone (TSH) levels] and the degree of hepatic steatosis [measured by Controlled Attenuation Parameter (CAP) score] will be recorded.	3 months after the procedure
Correlation between Hashimoto thyroiditis and metabolic dysfunction-associated steatotic liver disease	Correlation between Hashimoto thyroiditis and metabolic dysfunction-associated steatotic liver disease will be recorded.	3 months after the procedure

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: May 16, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hypothyroidism
• Other Study ID Numbers: Soh-Med-25-11-3MD

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