This prospective, single-center, two-group observational study evaluates a non-invasive multi-parameter diagnostic panel for metabolic dysfunction-associated steatotic liver disease (MASLD) in children with obesity. A total of 180 children aged 8 to 18 years with a body mass index at or above the 85th percentile for age and sex are planned for enrollment at a single tertiary pediatric center.
Each participant attends a single study visit comprising a fasting venous blood sample for serum biomarkers (cytokeratin-18 M30 and M65, fibroblast growth factor 21, retinol-binding protein 4, insulin-like growth factor binding protein 7, adiponectin, leptin, insulin, and routine biochemistry), abdominal ultrasonography with two-dimensional shear wave elastography, and genotyping of three MASLD-associated variants (PNPLA3 rs738409, TM6SF2 rs58542926, HSD17B13 rs72613567).
Participants are classified as MASLD-positive or MASLD-negative according to a guideline-based composite reference standard consisting of ultrasonographic steatosis grading and cardiometabolic risk factor criteria, assessed independently of the candidate index tests. The primary objective is to determine the discriminative performance, expressed as the area under the receiver operating characteristic curve, of a LASSO-regularized logistic regression model combining biomarker, elastography, and genetic predictors. No therapeutic intervention is assigned by the study protocol. Reporting will follow the STARD 2015 statement.
Who can participate
Age range
8 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 8 to 18 years.
* Body mass index at or above the 85th percentile for age and sex according to Turkish national growth references.
* Hepatic steatosis of grade 1 or higher on abdominal ultrasonography and/or alanine aminotransferase at or above the biology-based upper limit of normal (26 U/L for boys; 22 U/L for girls), or persistent alanine aminotransferase elevation at or above twice the upper limit of normal (50 U/L for boys; 44 U/L for girls).
* At least one cardiometabolic risk factor.
* Written informed consent provided by a parent or legal guardian, with simplified assent for children aged 8 to 11 years and standard assent for children aged 12 years and older.
Exclusion Criteria:
* Viral hepatitis.
* Autoimmune liver disease.
* Wilson disease, alpha-1 antitrypsin deficiency, or hereditary hemochromatosis.
* Use of hepatotoxic medication, including corticosteroids, methotrexate, valproate, amiodarone, or tamoxifen.
* Fasting duration shorter than 12 hours.
* Active infection, defined as C-reactive protein above 10 mg/L.
* Untreated thyroid disorder, defined as thyroid-stimulating hormone below 0.5 or above 5.
* Total parenteral nutrition.
* Diabetic ketoacidosis.
* Inability to obtain informed consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on developing a non-invasive diagnostic panel for MASLD in children with obesity — could this study help us get a clearer picture of whether my child actually has liver disease without needing a biopsy or more invasive testing?
2The trial is listed as 'not yet recruiting' — do you know when it might open for enrollment, and would it make sense to pursue standard diagnostic options like an ultrasound or blood tests in the meantime?
3Since this is a diagnostic study rather than a treatment trial, what would actually happen to my child's care if the panel identifies MASLD — would they receive treatment as part of the study, or would that be handled separately?
4My child has been diagnosed with obesity and may have insulin resistance — how does that combination affect their risk for MASLD, and is this the kind of study where participating could give us useful clinical information about their specific situation?
5Are there other ways to evaluate my child for MASLD right now that we should consider while this trial is still in the pre-recruitment stage, and how would you weigh those options against waiting to see if this study becomes available?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic Performance of the LASSO-Regularized Multi-Parameter Panel for MASLD
Timeframe: Through study completion, an average of 12 months