Association Between Overt and Sub-clinical Primary Hypothyroidism and Metabolic Dysfunction-Associated Steatoic Liver Disease in Non-Diabetic Patients
30 de maio de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Observacional
Inscrição (Estimado)
200
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Islam K Fathy, MSc
- Número de telefone: 00201011456295
- E-mail: islam.ali2@med.sohag.edu.eg
Locais de estudo
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Sohag Governorate
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Sohag, Sohag Governorate, Egito, 82511
- Recrutamento
- Sohag University
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Contato:
- Islam K Fathy, MSc
- Número de telefone: 00201011456295
- E-mail: islam.ali2@med.sohag.edu.eg
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Subinvestigador:
- Nayel A Zaki, MD
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Subinvestigador:
- Amal K Ahmed, MD
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Subinvestigador:
- Ahmed N Nour Eldin, MD
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Control Euthyroid group
Participants whom thyroid function tests are normal and screened for Metabolic dysfunction - associated Steatoic liver disease (MASLD).
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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).
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).
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|
Case group-1
Patients with overt primary hypothyroidism (High TSH and low FT4, FT3) that screening for Metabolic dysfunction - associated Steatoic liver disease (MASLD).
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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).
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).
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Case group-2
Patients with sub clinical hypothyroidism (High TSH and normal FT4, FT3) and screened for Metabolic dysfunction - associated Steatoic liver disease (MASLD).
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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).
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).
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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).
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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).
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).
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Assessment of the prevalence of metabolic dysfunction-associated steatotic liver disease
Prazo: 3 months after the procedure
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Prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) diagnosed by abdominal ultrasonography/FibroScan among adults with primary hypothyroidism will be assessed.
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3 months after the procedure
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Correlation between severity of primary hypothyroidism and the degree of hepatic steatosis
Prazo: 3 months after the procedure
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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.
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3 months after the procedure
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Correlation between Hashimoto thyroiditis and metabolic dysfunction-associated steatotic liver disease
Prazo: 3 months after the procedure
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Correlation between Hashimoto thyroiditis and metabolic dysfunction-associated steatotic liver disease will be recorded.
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3 months after the procedure
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de março de 2026
Conclusão Primária (Estimado)
1 de março de 2027
Conclusão do estudo (Estimado)
1 de março de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
16 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de maio de 2026
Primeira postagem (Real)
22 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Soh-Med-25-11-3MD
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Prazo de Compartilhamento de IPD
After the end of study for one year.
Critérios de acesso de compartilhamento IPD
The data will be available upon a reasonable request from the corresponding author.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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