Hypothyroidism and Liver Fibrosis Severity in MASLD

NCT07793279 | Not Yet Recruiting

• 1 other identifier: Hypothyroid & MASLD Fibrosis
• Study Type: observational
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

MASLD; NAFLD; Liver Fibrosis; Transient Elastography; FibroScan; FIB-4 Index; NAFLD Fibrosis Score; Subclinical Hypothyroidism; Thyroid Stimulating Hormone

Outcome Measures

Primary Outcomes (1)

• Liver Stiffness Measurement (LSM)

  Liver stiffness measurement assessed by transient elastography (FibroScan), measured in kilopascals (kPa), where higher values indicate greater hepatic fibrosis severity.

  Baseline

Study Arms (2)

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).

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).

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 or older attending Assiut University Hospital diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD), confirmed by abdominal ultrasound and at least one cardiometabolic risk factor. The population includes patients with concomitant primary hypothyroidism (cases) and patients with normal thyroid function (controls).

You may qualify if:

• Adult patients aged 18 years or older.
• Confirmed diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD), defined as hepatic steatosis on abdominal ultrasound along with at least one cardiometabolic risk factor (e.g., overweight/obesity, type 2 diabetes mellitus, or hypertension).
• Thyroid status: Patients with diagnosed primary hypothyroidism (either overt or subclinical hypothyroidism) for the case group, or confirmed normal thyroid function (euthyroid) for the control group.
• Availability of complete clinical and laboratory data necessary to calculate non-invasive fibrosis scores (FIB-4 index and NAFLD Fibrosis Score).
• Willingness to provide written informed consent.

You may not qualify if:

• Thyroid-related: Hyperthyroidism, history of thyroidectomy, or radioactive iodine therapy.
• Liver-related: Chronic viral hepatitis (HBV, HCV), autoimmune hepatitis, primary biliary cholangitis, Wilson's disease, hemochromatosis, or other specific chronic liver diseases.
• Decompensated liver cirrhosis or hepatocellular carcinoma (HCC).
• Significant alcohol consumption (to exclude alcohol-related liver disease).
• General/systemic: End-stage renal disease (ESRD) or congestive heart failure.
• Pregnancy or lactation.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Hypothyroidism; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08