Hypothyroidism and Liver Fibrosis Severity in MASLD

Sponsor
Assiut University
Study ID
NCT07793279
Status
Not Yet Recruiting

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Conditions

  • Hypothyroidism
  • Liver Cirrhosis
  • Metabolic Dysfunction-Associated Steatotic Liver Disease
  • Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease worldwide, characterized by excess fat accumulation in the liver associated with metabolic risk factors such as obesity and type 2 diabetes. Over time, MASLD can progress from simple liver fat accumulation to liver inflammation and fibrosis (scar tissue formation), which is the most critical factor predicting long-term liver health complications. Thyroid hormones play a key role in controlling hepatic metabolism and lipid handling. An underactive thyroid gland (hypothyroidism), including both overt and mild (subclinical) forms, has been linked to increased fat accumulation and advanced fibrosis in the liver. However, further evidence is needed regarding how thyroid dysfunction relates to liver fibrosis using modern, non-invasive assessment tools in clinical practice. The primary purpose of this observational case-control study is to evaluate the relationship between hypothyroidism and the severity of liver fibrosis in adult patients with MASLD. Participants diagnosed with MASLD will be categorized into two groups based on thyroid function: patients with hypothyroidism (cases) and patients with normal thyroid function (controls). All participants will undergo standard clinical assessments, routine fasting laboratory tests, thyroid function tests, abdominal ultrasound, and transient elastography (FibroScan) to measure liver stiffness and fibrosis severity non-invasively. Non-invasive fibrosis scores, including the FIB-4 index and the NAFLD Fibrosis Score (NFS), will also be calculated. The findings will help determine whether hypothyroidism is independently associated with more severe liver fibrosis in patients with MASLD, potentially guiding screening and management strategies.

Key Dates

First listed
Aug 28, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
85 participants (estimated)

Arms

  • Arm: MASLD With Hypothyroidism
    Adult patients diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD) who have concomitant primary hypothyroidism (either overt hypothyroidism, defined as elevated TSH with low free T4, or subclinical hypothyroidism, defined as elevated TSH with normal free T4).
  • Arm: MASLD With Euthyroidism
    Adult patients diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD) who have normal thyroid function (euthyroid state, defined as normal serum TSH and free T4 levels).

Primary Outcome Measure

Liver Stiffness Measurement (LSM) [ Time Frame: Baseline ]

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