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

The patient population for the trial will be derived from Sohag University hospital/ Endocrine or Hepatology outpatient clinic.

The study protocol will be approved by the Ethics Committee of Sohag Faculty of Medicine.

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.