Association Between Overt and Sub-clinical Primary Hypothyroidism and Metabolic Dysfunction-Associated Steatoic Liver Disease in Non-Diabetic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FibroScan, Thyroid Function Assessment.
- Who it may be relevant to
- Registry conditions: Overt, Sub-clinical, Primary Hypothyroidism, Metabolic Dysfunction-Associated Steatoic Liver Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Association Between Overt and Sub-clinical Primary Hypothyroidism and Metabolic Dysfunction-Associated Steatoic Liver Disease (MASLD) in Non-Diabetic Patients
Overview
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 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
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).
Primary outcome measures
- Assessment of the prevalence of metabolic dysfunction-associated steatotic liver disease [Time frame: 3 months after the procedure]
Secondary outcome measures (2)
- Correlation between severity of primary hypothyroidism and the degree of hepatic steatosis [Time frame: 3 months after the procedure]
- Correlation between Hashimoto thyroiditis and metabolic dysfunction-associated steatotic liver disease [Time frame: 3 months after the procedure]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Egypt · 1 center
- Sohag University — Sohag
Identifiers
NCT: NCT07603817 · Soh-Med-25-11-3MD