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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSohag University

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • FibroScan

    Diagnostic test

    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).

  • Thyroid Function Assessment

    Diagnostic test

    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).

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Control Euthyroid group2 interventions
Group B: Case group-12 interventions
Group C: Case group-22 interventions
Group D: Case group-32 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months after the procedure

Secondary outcomes

1

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.

Time frame
3 months after the procedure
2

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.

Time frame
3 months after the procedure

Other outcomes

Sponsors and contacts

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