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

NCT07603817 | Recruiting

• 1 other identifier: Soh-Med-25-11-3MD
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overt; Sub-clinical; Primary Hypothyroidism; Metabolic Dysfunction-Associated Steatoic Liver Disease; Non-Diabetic Patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Correlation between severity of primary hypothyroidism and the degree of hepatic steatosis

  3 months after the procedure

• Correlation between Hashimoto thyroiditis and metabolic dysfunction-associated steatotic liver disease

  3 months after the procedure

Study Arms (4)

Control Euthyroid group

Participants whom thyroid function tests are normal and screened for Metabolic dysfunction - associated Steatoic liver disease (MASLD).

Diagnostic Test: FibroScan; Diagnostic Test: Thyroid Function Assessment

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; Diagnostic Test: Thyroid Function Assessment

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; Diagnostic Test: Thyroid Function Assessment

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; Diagnostic Test: Thyroid Function Assessment

Interventions

FibroScan DIAGNOSTIC_TEST

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; Case group-2; Case group-3; Control Euthyroid group

Thyroid Function Assessment DIAGNOSTIC_TEST

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; Case group-2; Case group-3; Control Euthyroid group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, 82511, Egypt

RECRUITING

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Central Study Contacts

Islam K Fathy, MSc

CONTACT

00201011456295; islam.ali2@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Internal Medicine, Sohag University, Egypt.

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: May 22, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

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)