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Overt and Sub-clinical Primary Hypothyroidism and Metabolic Dysfunction-Associated Steatoic Liver Disease in Non-Diabetic Patients
RECRUITINGSponsored by Sohag University
Actively Recruiting
SponsorSohag University
Started2026-03-01
Est. completion2027-03-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07603817
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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.
Conditions6
Liver DiseaseMetabolic Dysfunction-Associated Steatoic Liver DiseaseNon-Diabetic PatientsOvertPrimary HypothyroidismSub-clinical
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Actively Recruiting
SponsorSohag University
Started2026-03-01
Est. completion2027-03-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07603817