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Overt and Sub-clinical Primary Hypothyroidism and Metabolic Dysfunction-Associated Steatoic Liver Disease in Non-Diabetic Patients

21. maj 2026 opdateret af: Islam Khaled Fathy, Sohag University

Association Between Overt and Sub-clinical Primary Hypothyroidism and Metabolic Dysfunction-Associated Steatoic Liver Disease (MASLD) in Non-Diabetic Patients

This study aims to estimate the prevalence of Metabolic dysfunction - associated Steatoic liver disease (MASLD) among adults with primary hypothyroidism (overt or sub-clinical 1ry hypothyroidism) and prevalence of MASLD in Hashimoto-thyroiditis vs Euthyroid controls in non-diabetic patients.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Metabolic dysfunction - associated Steatoic liver disease (MASLD), previously known as non-alcoholic fatty liver disease (NAFLD), has become the leading cause of chronic liver disease globally.

Metabolic dysfunction -associated Steatoic liver disease (MASLD) is the prevailing chronic hepatic disorder, where it is characterized by hepatic steatosis affecting more than 5% of hepatocyte in absence of excessive alcohol consumption (> 30g/ day for men and >20g/day for women), or other underlying chronic liver diseases, and it is commonly associated metabolic risk factors such as obesity and type 2 diabetes.

Hypothyroidism is characterized by the reduction or absence of thyroid hormones.it can be manifest at birth as (congenital) or develop later (acquired). The most common cause of hypothyroidism is primary hypothyroidism due to dysfunction of the thyroid gland.

Overt hypothyroidism is a prevalent clinical thyroid disorder characterized by elevated serum thyrotropin (TSH) levels as well as reduced free thyroxine (FT4) levels.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Egypten
      • Sohag, Egypten, 82511
        • Rekruttering
        • Sohag University
        • Kontakt:
        • Underforsker:
          • Nayel A Zaki, MD
        • Underforsker:
          • Amal K Ahmed, MD
        • Underforsker:
          • Ahmed N Nour Eldin, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The patient population for the trial will be derived from Sohag University hospital/ Endocrine or Hepatology outpatient clinic.

The study protocol will be approved by the Ethics Committee of Sohag Faculty of Medicine.

Beskrivelse

Inclusion Criteria:

  • Patients aged ≥18years old who will be:
  • Diagnosed with primary hypothyroidism (overt or sub clinical hypothyroidism) within 3 months with or without levothyroxine treatment.
  • Patients with positive antibody (positive TPO antibody or positive Thyroglobin antibody) irrespective of thyroid status
  • Metabolic dysfunction-associated steatotic liver disease (MASLD) assessment by ultrasound and Fibro-scan.

Exclusion Criteria:

  • Diabetic patients according to American Diabetes Association (ADA) Criteria.
  • Excessive Alcohol consumption (> 30 gm/ day in men, 20 gm /day in women.
  • Body mass index (BMI) index >40 kg/m2
  • Other causes of chronic hepatic steatosis [e.g., positive hepatitis B virus (HBV), positive hepatitis C virus (HCV)), autoimmune disease, Wilson disease, drugs].
  • Patients use of drugs known to cause hepatic steatosis (e.g., amiodarone, valproate, tamoxifen, methotrexate, steroids).
  • Treatment with drugs that influence liver fat, as thiazolidinediones, α-glucosidase inhibitors, sodium-glucose -transporter 2 (SGLT2) inhibitors or any glucagon-like peptide-1 receptor agonists during the previous 3 months.
  • Detection of biliary duct obstruction based on imaging studies.
  • Evidence of cirrhosis [on basis of ultrasonography and magnetic resonance imaging (MRI )] or hepatocellular carcinoma [evidence on triphasic Computed Tomography (CT) or MRI].
  • Presence of any systemic disease that commonly cause liver disease.
  • Severe hepatic injury and/or significant abnormal liver function defined as aspartate aminotransferase >5× upper limit of normal (ULN) and/or alanine aminotransferase >5× ULN or elevated total bilirubin > 2 mg/dl.
  • Pregnant women.
  • Patients with active malignancy.
  • History of bariatric surgery or ongoing weight-loss diet (hypocaloric diet) or use of weight-loss agents unless the diet or treatment has been stopped at least 3 months before screening and that the patient has had a stable body weight (+/- 3 kg) during the 3 months before screening.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Control Euthyroid group
Participants whom thyroid function tests are normal and screened for Metabolic dysfunction - associated Steatoic liver disease (MASLD).
Diagnostisk test: FibroScan
Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).
Diagnostisk test: Thyroid Function Assessment
Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).
Case group-1
Patients with overt primary hypothyroidism (High TSH and low FT4, FT3) that screening for Metabolic dysfunction - associated Steatoic liver disease (MASLD).
Diagnostisk test: FibroScan
Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).
Diagnostisk test: Thyroid Function Assessment
Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).
Case group-2
Patients with sub clinical hypothyroidism (High TSH and normal FT4, FT3) and screened for Metabolic dysfunction - associated Steatoic liver disease (MASLD).
Diagnostisk test: FibroScan
Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).
Diagnostisk test: Thyroid Function Assessment
Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).
Case group-3
Patients with positive thyroid auto-antibodies (normal TSH, normal FT4, normal FT3, Positive TPo antibody or positive thyroglobin antibody) screened for Metabolic dysfunction - associated Steatoic liver disease (MASLD).
Diagnostisk test: FibroScan
Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).
Diagnostisk test: Thyroid Function Assessment
Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assessment of the prevalence of metabolic dysfunction-associated steatotic liver disease
Tidsramme: 3 months after the procedure
Prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) diagnosed by abdominal ultrasonography/FibroScan among adults with primary hypothyroidism will be assessed.
3 months after the procedure

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation between severity of primary hypothyroidism and the degree of hepatic steatosis
Tidsramme: 3 months after the procedure
Correlation between severity of primary hypothyroidism [measured by Thyroid-stimulating hormone (TSH) levels] and the degree of hepatic steatosis [measured by Controlled Attenuation Parameter (CAP) score] will be recorded.
3 months after the procedure
Correlation between Hashimoto thyroiditis and metabolic dysfunction-associated steatotic liver disease
Tidsramme: 3 months after the procedure
Correlation between Hashimoto thyroiditis and metabolic dysfunction-associated steatotic liver disease will be recorded.
3 months after the procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sohag University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2026

Primær færdiggørelse (Anslået)

1. marts 2027

Studieafslutning (Anslået)

1. marts 2027

Datoer for studieregistrering

Først indsendt

16. maj 2026

Først indsendt, der opfyldte QC-kriterier

21. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Soh-Med-25-11-3MD

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD-delingstidsramme

After the end of study for one year.

IPD-delingsadgangskriterier

The data will be available upon a reasonable request from the corresponding author.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

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Kliniske forsøg med Primær hypothyroidisme

Kliniske forsøg med FibroScan

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