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

NCT07827430 | Not Yet Recruiting

• 1 other identifier: Hypothyroid in MASLD Fibrosis
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-Alcoholic Fatty Liver Disease; Hypothyroidism; Liver Fibrosis; Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

Subclinical Hypothyroidism; Overt Hypothyroidism; Transient Elastography; FibroScan; FIB-4 Index; NAFLD Fibrosis Score; Hepatic Steatosis; Liver Stiffness Measurement

Outcome Measures

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.

  Baseline

Study Arms (2)

MASLD with Hypothyroidism (Cases)

Adult patients diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD) who have overt hypothyroidism (elevated serum TSH with low free T4) or subclinical hypothyroidism (elevated serum TSH with normal free T4). All participants undergo standardized clinical assessment, laboratory investigations, abdominal ultrasound, transient elastography (FibroScan), and calculation of non-invasive fibrosis scores (FIB-4 and NAFLD Fibrosis Score).

MASLD Euthyroid (Controls)

Adult patients diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD) with normal thyroid function tests (normal serum TSH and free T4 levels). All participants undergo the identical diagnostic evaluation, including clinical examination, laboratory investigations, abdominal ultrasound, transient elastography (FibroScan), and calculation of non-invasive fibrosis scores (FIB-4 and NAFLD Fibrosis Score).

Eligibility Criteria

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

Study 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.

You may qualify if:

• 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).
• Provision of written informed consent to participate in the study.

You may not qualify if:

• 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).
• Significant alcohol consumption (to exclude alcohol-related liver disease).
• End-stage renal disease (ESRD).
• Congestive heart failure.
• Pregnancy or lactation.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Hypothyroidism; Liver Cirrhosis; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Thyroid Diseases; Endocrine System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Internal Medicine

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09