About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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].
Trial population
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.
Trial design
Case-control
Prospective
Treatments tested in this trial
FibroScan
Diagnostic testParticipants 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).
Thyroid Function Assessment
Diagnostic testParticipants 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).
Treatment groups
Trial outcomes
Primary outcomes
Assessment of the prevalence of metabolic dysfunction-associated steatotic liver disease
Prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) diagnosed by abdominal ultrasonography/FibroScan among adults with primary hypothyroidism will be assessed.
Secondary outcomes
Correlation between severity of primary hypothyroidism and the degree of hepatic steatosis
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
Correlation between Hashimoto thyroiditis and metabolic dysfunction-associated steatotic liver disease will be recorded.
Sponsors and contacts
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