Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

30 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

200

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Egitto
    • Sohag Governorate
      • Sohag, Sohag Governorate, Egitto, 82511
        • Reclutamento
        • Sohag University
        • Contatto:
        • Sub-investigatore:
          • Nayel A Zaki, MD
        • Sub-investigatore:
          • Amal K Ahmed, MD
        • Sub-investigatore:
          • Ahmed N Nour Eldin, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Control Euthyroid group
Participants whom thyroid function tests are normal and screened for Metabolic dysfunction - associated Steatoic liver disease (MASLD).
Test diagnostico: 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).
Test diagnostico: 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).
Test diagnostico: 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).
Test diagnostico: 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).
Test diagnostico: 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).
Test diagnostico: 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).
Test diagnostico: 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).
Test diagnostico: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Assessment of the prevalence of metabolic dysfunction-associated steatotic liver disease
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Correlation between severity of primary hypothyroidism and the degree of hepatic steatosis
Lasso di tempo: 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
Lasso di tempo: 3 months after the procedure
Correlation between Hashimoto thyroiditis and metabolic dysfunction-associated steatotic liver disease will be recorded.
3 months after the procedure

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sohag University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 marzo 2026

Completamento primario (Stimato)

1 marzo 2027

Completamento dello studio (Stimato)

1 marzo 2027

Date di iscrizione allo studio

Primo inviato

16 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 maggio 2026

Primo Inserito (Effettivo)

22 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Soh-Med-25-11-3MD

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Periodo di condivisione IPD

After the end of study for one year.

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su FibroScan

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Algeria

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi