Impact of Overt and Subclinical Hypothyroidism on Liver Fibrosis in Patients With MASLD

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

Metabolic dysfunction-associated steatotic liver disease (MASLD), previously known as non-alcoholic fatty liver disease (NAFLD), is one of the most common chronic liver conditions globally. The progression of liver fibrosis (scarring) represents the most critical determinant of long-term liver-related morbidity and mortality in these patients. Thyroid hormones play an essential role in hepatic lipid metabolism, and thyroid dysfunction, specifically overt and subclinical hypothyroidism, has been implicated in the development and progression of MASLD. However, evidence regarding whether hypothyroidism independently worsens liver fibrosis severity remains inconsistent. This study aims to investigate the association between overt and subclinical hypothyroidism and the stages of liver fibrosis in adult Egyptian patients with MASLD using non-invasive diagnostic tools.

A total of 120 adult patients diagnosed with MASLD attending the outpatient hepatology and endocrinology clinics at Assiut University Hospital will be enrolled, consisting of 60 patients with hypothyroidism and 60 euthyroid controls. All participants will undergo standardized clinical assessments, anthropometric measurements, and laboratory investigations, including thyroid function panels (TSH and free T4), liver function tests, lipid profiles, and glycemic markers. Hepatic steatosis will be evaluated via abdominal ultrasound, while liver fibrosis severity will be assessed using transient elastography (FibroScan) to measure liver stiffness, alongside validated blood-based scoring models (FIB-4 index and NAFLD Fibrosis Score). Comparing these findings across groups will help clarify whether thyroid deficiency acts as an independent contributor to advanced liver fibrosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients aged > 18 years.

Confirmed diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD), defined as hepatic steatosis on abdominal ultrasound in the presence of at least one cardiometabolic risk factor (e.g., overweight/obesity, type 2 diabetes, or hypertension).

Newly diagnosed or pre-existing overt or subclinical hypothyroidism (for cases) or documented euthyroid status (for controls).

Availability of complete clinical and laboratory data required to calculate non-invasive liver fibrosis scores (FIB-4 index and NAFLD Fibrosis Score).

Disqualifiers

Hyperthyroidism, history of thyroidectomy, or prior radioactive iodine therapy.

Chronic viral hepatitis (hepatitis B virus or hepatitis C virus).

Other secondary or specific chronic liver diseases (autoimmune hepatitis, primary biliary cholangitis, Wilson's disease, or hemochromatosis).

Decompensated liver cirrhosis or established hepatocellular carcinoma (HCC).

Trial population

Adult patients aged \> 18 years diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD) who attend the outpatient hepatology and endocrinology clinics at Assiut University Hospital, Assiut, Egypt. The population includes MASLD patients with newly diagnosed or pre-existing overt or subclinical hypothyroidism, as well as euthyroid MASLD patients.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 2 trial groups
Group A: MASLD with Hypothyroidism (Cases)
Group B: MASLD Euthyroid (Controls)

Trial outcomes

Primary outcomes

1

Liver Stiffness Measurement (LSM)

Liver stiffness will be measured using transient elastography (FibroScan) and expressed in kilopascals (kPa). Measurements will be obtained via the standard M or XL probe according to patient body habitus, requiring at least 10 valid acquisitions with an interquartile range-to-median ratio (IQR/M) ≤ 30% for reliability. Higher values represent greater liver stiffness and more severe hepatic fibrosis.

Time frame
Baseline

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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