Actively Recruiting
Association Between Overt and Sub-clinical Primary Hypothyroidism and Metabolic Dysfunction-Associated Steatoic Liver Disease in Non-Diabetic Patients
Led by Sohag University · Updated on 2026-06-02
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the prevalence of Metabolic Dysfunction-Associated Steatoic Liver Disease (MASLD) in adults with primary hypothyroidism, including both overt and sub-clinical forms, and comparing it to euthyroid controls among non-diabetic patients. MASLD, previously called non-alcoholic fatty liver disease, is a common chronic liver condition linked to metabolic issues like obesity and type 2 diabetes. The study also explores the relationship between Hashimoto thyroiditis and MASLD. Participants include groups with normal thyroid function, overt primary hypothyroidism, sub-clinical hypothyroidism, and those with positive thyroid auto-antibodies. All groups undergo thyroid function tests and MASLD screening using laboratory tests, abdominal ultrasound, and vibration-controlled transient elastography (FibroScan). This observational study follows these assessments to estimate MASLD prevalence and its correlation with thyroid disease severity. During the study, participants will have thyroid function and liver assessments performed, including blood tests and imaging. Researchers will measure the prevalence of MASLD and examine links between hypothyroidism severity, Hashimoto thyroiditis, and liver condition over three months. The study aims to provide insights into liver disease in thyroid patients without diabetes, with participant involvement lasting through these evaluations and follow-up measurements.
CONDITIONS
Brief Title
Association Between Overt and Sub-clinical Primary Hypothyroidism and Metabolic Dysfunction-Associated Steatoic Liver Disease in Non-Diabetic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Diagnosed with primary hypothyroidism (overt or sub-clinical) within the past 3 months, with or without levothyroxine treatment
- Patients with positive thyroid antibodies (positive TPO antibody or thyroglobulin antibody) regardless of thyroid status
- Undergoing assessment for metabolic dysfunction-associated steatoic liver disease (MASLD) by ultrasound and FibroScan
You will not qualify if you...
- Diagnosed with diabetes according to American Diabetes Association criteria
- Excessive alcohol consumption (>30 g/day for men, >20 g/day for women)
- Body mass index (BMI) over 40 kg/m2
- Other causes of chronic liver steatosis such as hepatitis B or C, autoimmune disease, Wilson disease, or drug-induced steatosis
- Use of drugs known to cause hepatic steatosis (e.g., amiodarone, valproate, tamoxifen, methotrexate, steroids)
- Treatment with medications affecting liver fat (e.g., thiazolidinediones, alpha-glucosidase inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists) in the prior 3 months
- Biliary duct obstruction detected by imaging
- Evidence of cirrhosis or hepatocellular carcinoma
- Presence of systemic diseases causing liver disease
- Severe liver injury or significant abnormal liver function
- Pregnancy
- Active malignancy
- History of bariatric surgery or current weight-loss diet/agents unless stopped at least 3 months before screening with stable body weight during that time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants 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).
1 visit (in-person)
Duration - 3 months after diagnostic evaluation
Participants are monitored to assess the prevalence and correlation of metabolic dysfunction-associated steatotic liver disease with thyroid status over the study period.
Follow-up assessments as scheduled
Trial Site Locations
Total: 1 location
1
Sohag University
Sohag, Sohag Governorate, Egypt, 82511
Actively Recruiting
Research Team
I
Islam K Fathy, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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