NCT07603817 Association Between Overt and Sub-clinical Primary Hypothyroidism and Metabolic Dysfunction-Associated Steatoic Liver Disease in Non-Diabetic Patients
| NCT ID | NCT07603817 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sohag University |
| Condition | Overt |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2026-03-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07603817 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Overt. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07603817 currently recruiting?
Yes, NCT07603817 is actively recruiting participants. Contact the research team at islam.ali2@med.sohag.edu.eg for enrollment information.
Where is the NCT07603817 trial being conducted?
This trial is being conducted at Sohag, Egypt.
Who is sponsoring the NCT07603817 clinical trial?
NCT07603817 is sponsored by Sohag University. The trial plans to enroll 200 participants.