Non-Invasive Diagnostic Panel for MASLD in Children With Obesity
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Conditions studied: Metabolic Dysfunction-Associated Steatotic Liver Disease, Pediatric Obesity, Insulin Resistance Syndrome
In brief
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.
Key facts
- Study ID
- NCT07731360
- Run by
- Kayseri City Hospital
- People needed
- 180
- Starts
- 2026-07-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-07-30
Who can join
Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Kayseri City Hospital — Kayseri, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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