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

N/ANot Yet RecruitingNCT07827430

Assiut University120 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease Non-Alcoholic Fatty Liver Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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