Metabolic Dysfunction-Associated Steatoic Liver Disease, Non-Diabetic Patients, Overt, Primary Hypothyroidism, Sub-clinical
Conditions
Brief 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.
Detailed description
Metabolic dysfunction - associated Steatoic liver disease (MASLD), previously known as non-alcoholic fatty liver disease (NAFLD), has become the leading cause of chronic liver disease globally. Metabolic dysfunction -associated Steatoic liver disease (MASLD) is the prevailing chronic hepatic disorder, where it is characterized by hepatic steatosis affecting more than 5% of hepatocyte in absence of excessive alcohol consumption (\> 30g/ day for men and \>20g/day for women), or other underlying chronic liver diseases, and it is commonly associated metabolic risk factors such as obesity and type 2 diabetes. Hypothyroidism is characterized by the reduction or absence of thyroid hormones.it can be manifest at birth as (congenital) or develop later (acquired). The most common cause of hypothyroidism is primary hypothyroidism due to dysfunction of the thyroid gland. Overt hypothyroidism is a prevalent clinical thyroid disorder characterized by elevated serum thyrotropin (TSH) levels as well as reduced free thyroxine (FT4) levels.
Interventions
DIAGNOSTIC_TESTFibroScan
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_TESTThyroid Function Assessment
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).
Sponsors
Sohag University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the prevalence of metabolic dysfunction-associated steatotic liver disease | 3 months after the procedure | Prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) diagnosed by abdominal ultrasonography/FibroScan among adults with primary hypothyroidism will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between severity of primary hypothyroidism and the degree of hepatic steatosis | 3 months after the procedure | Correlation between severity of primary hypothyroidism \[measured by Thyroid-stimulating hormone (TSH) levels\] and the degree of hepatic steatosis \[measured by Controlled Attenuation Parameter (CAP) score\] will be recorded. |
| Correlation between Hashimoto thyroiditis and metabolic dysfunction-associated steatotic liver disease | 3 months after the procedure | Correlation between Hashimoto thyroiditis and metabolic dysfunction-associated steatotic liver disease will be recorded. |
Countries
Egypt
Contacts
CONTACTIslam K Fathy, MSc
Outcome results
None listed