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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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).
• Диагностический тест 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).

Первичные конечные точки

• Assessment of the prevalence of metabolic dysfunction-associated steatotic liver disease [Срок оценки: 3 months after the procedure]

Вторичные конечные точки (2)

• Correlation between severity of primary hypothyroidism and the degree of hepatic steatosis [Срок оценки: 3 months after the procedure]
• Correlation between Hashimoto thyroiditis and metabolic dysfunction-associated steatotic liver disease [Срок оценки: 3 months after the procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Египет · 1 центр

• Sohag University — Sohag

Идентификаторы

NCT: NCT07603817 · Soh-Med-25-11-3MD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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