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Hypothyroidism and Liver Fibrosis Severity in MASLD

26. august 2026 oppdatert av: Mina Atef Lamey Khalil, Assiut University

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.

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.

Studieoversikt

Studietype

Observasjonsmessig

Registrering (Antatt)

85

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

N/A

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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).

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Liver Stiffness Measurement (LSM)
Tidsramme: Baseline
Liver stiffness measurement assessed by transient elastography (FibroScan), measured in kilopascals (kPa), where higher values indicate greater hepatic fibrosis severity.
Baseline

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. oktober 2027

Studiet fullført (Antatt)

1. november 2027

Datoer for studieregistrering

Først innsendt

26. august 2026

Først innsendt som oppfylte QC-kriteriene

26. august 2026

Først lagt ut (Faktiske)

28. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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