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RECRUITING

NCT07603817

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

Sponsor: Sohag University

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2026-03-01

Completion Date

2027-03-01

Last Updated

2026-05-22

Healthy Volunteers

Conditions

Overt Sub-clinical Primary Hypothyroidism Metabolic Dysfunction-Associated Steatoic Liver Disease Non-Diabetic Patients

Interventions

DIAGNOSTIC_TEST

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).

DIAGNOSTIC_TEST

Thyroid Function Assessment

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.

Locations (1)

Sohag University

Sohag, Egypt