Metabolic Dysfunction-Associated Steatotic Liver DiseaseNCT07793279
Hypothyroidism and Liver Fibrosis Severity in MASLD
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease and Hypothyroidism, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Hypothyroidism, Liver Cirrhosis
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: The Relation Between Hypothyroidism and the Severity of Liver Fibrosis in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
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.
Read more
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
- Medical subject headings
- Hypothyroidism, Liver Cirrhosis, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Stiffness Measurement (LSM)
Liver stiffness measurement assessed by transient elastography (FibroScan), measured in kilopascals (kPa), where higher values indicate greater hepatic fibrosis severity.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Atef Lamey Khalil, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793279
- Sponsor's protocol ID
- Hypothyroid & MASLD Fibrosis
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No