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临床试验/NCT07827430
NCT07827430尚未招募不适用

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

Assiut University0 个研究点目标入组 120 人开始时间: 2026年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
Liver Stiffness Measurement (LSM)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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).

结局指标

主要结局

Liver Stiffness Measurement (LSM)

时间窗: Baseline

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mina Atef Lamey Khalil

Resident of Internal Medicine

Assiut University

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