Impact of Overt and Subclinical Hypothyroidism on Liver Fibrosis in Patients With MASLD
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.
Tutkimuksen yleiskatsaus
Tila
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
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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).
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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).
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Liver Stiffness Measurement (LSM)
Aikaikkuna: Baseline
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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.
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Baseline
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Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- Hypothyroid in MASLD Fibrosis
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