Link Between Overt or Subclinical Hypothyroidism and MASLD in Non-Diabetic Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study estimates the prevalence of metabolic dysfunction-associated steatohepatitis in adults with primary hypothyroidism and compares MASLD prevalence between Hashimoto's thyroiditis and euthyroid controls who are non-diabetic. It uses ultrasound and FibroScan to assess MASLD and thyroid function tests to characterize thyroid status. The design is observational and cross-sectional, focusing on adults aged 18 and older with recent documentation of primary hypothyroidism, with exclusion of diabetes and other major liver-confounding conditions. The investigation aims to help clarify the relationship between thyroid dysfunction and liver fat-related disease in non-diabetic individuals.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sohag University
  Sohag, Sohag Governorate, Egypt Recruiting

Study contacts

• Study coordinator: Islam K Fathy, MSc
• Email: islam.ali2@med.sohag.edu.eg
• Phone: 00201011456295

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.