Clinical trial

Non-Invasive Diagnostic Panel for MASLD in Children With Obesity

Opening soon · Not applicable · 1 countries · Registry ID NCT07731360

Opening soonNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age8 Years to 18 Years

SexAll

Healthy volunteersNot accepted

ConditionMetabolic Dysfunction-Associated Steatotic Liver Disease, Pediatric Obesity, Insulin Resistance Syndrome

Full registry criteria

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.

Treatments and study arms

Non-Invasive Multi-Parameter Diagnostic Panel

Diagnostic Test

All participants undergo the same set of index tests at a single study visit: a fasting venous blood sample for serum 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 measured by enzyme-linked immunosorbent assay and standard laboratory methods; abdominal ultrasonography with two-dimensional shear wave elastography for liver stiffness; and genotyping of PNPLA3 rs738409, TM6SF2 rs58542926 and HSD17B13 rs72613567 for derivation of a three-variant polygenic risk score. These are observational measurements; no therapeutic intervention is administered.

Primary outcomes

Diagnostic Performance of the LASSO-Regularized Multi-Parameter Panel for MASLDThrough study completion, an average of 12 months

Discriminative performance of a LASSO-regularized logistic regression model combining serum biomarkers (cytokeratin-18 M30, cytokeratin-18 M65, fibroblast growth factor 21, retinol-binding protein 4, insulin-like growth factor binding protein 7), homeostatic model assessment of insulin resistance, liver stiffness measured by two-dimensional shear wave elastography, and a three-variant polygenic risk score, for classifying participants against the composite reference standard for MASLD. Metric: area under the receiver operating characteristic curve with bootstrap-derived 95% confidence interval.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Kayseri City Hospital🌐 Kayseri, Turkey (Türkiye)

Open map

Agah B ÖZTÜRK, Principal Investigator, Department of Pediatrics, MDContact

Email · Call +90 352 315 77 00