Metabolic Dysfunction-Associated Steatotic Liver DiseaseNCT07827430
Impact of Overt and Subclinical Hypothyroidism on Liver Fibrosis in Patients With MASLD
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease and Non-Alcoholic Fatty Liver Disease, run by Assiut University.
Trial summary
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. 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, Non-Alcoholic Fatty Liver Disease, Hypothyroidism
- How many people
- 120 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 diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD) who attend the outpatient hepatology and endocrinology clinics at Assiut University Hospital, Assiut, Egypt. The population includes MASLD patients with newly diagnosed or pre-existing overt or subclinical hypothyroidism, as well as euthyroid MASLD patients.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Impact of Overt and Subclinical Hypothyroidism on Different Stages of Liver Fibrosis in Patients With MASLD
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.
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-Alcoholic Fatty Liver Disease, Hypothyroidism, Liver Fibrosis
- Keywords
- Subclinical Hypothyroidism, Overt Hypothyroidism, Transient Elastography, FibroScan, FIB-4 Index, NAFLD Fibrosis Score, Hepatic Steatosis, Liver Stiffness Measurement
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Hypothyroidism, Liver Cirrhosis, Fatty Liver
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 (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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 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
- 120 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
- NCT07827430
- Sponsor's protocol ID
- Hypothyroid in MASLD Fibrosis
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No