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NCT07603817Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 2 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
16 May 2026
Start date
Mar 2026
Primary completion date
Mar 2027
Lead sponsor
Sohag University
NCT number
NCT07603817

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From Mar 2026 to the primary completion date, Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients use of drugs known to cause hepatic steatosis (e.g., amiodarone, valproate, tamoxifen, methotrexate, steroids).
  • 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.

Other illness

  • Diabetic patients according to American Diabetes Association (ADA) Criteria.
  • Other causes of chronic hepatic steatosis \[e.g., positive hepatitis B virus (HBV), positive hepatitis C virus (HCV)), autoimmune disease, Wilson disease, drugs\].
  • Presence of any systemic disease that commonly cause liver disease.
  • Patients with active malignancy.

Lab values

  • 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.
  • 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.

Other

  • Excessive Alcohol consumption (\> 30 gm/ day in men, 20 gm /day in women.
  • Body mass index (BMI) index \>40 kg/m2
  • Detection of biliary duct obstruction based on imaging studies.
  • Evidence of cirrhosis \[on basis of ultrasonography and magnetic resonance imaging (MRI )\] or hepatocellular carcinoma \[evidence on triphasic Computed Tomography (CT) or MRI\].
  • Pregnant women.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sohag University
Coordinator of this site? Confirm its status
SohagEgyptRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.