๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Patients aged โฅ18years 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, ฮฑ-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 \>5ร upper limit of normal (ULN) and/or alanine aminotransferase \>5ร 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.