A blood and ultrasound panel to detect fatty liver disease in children with obesity
Tests a non-invasive panel for fatty liver disease in children with obesity.
Plain-language title generated from the registry record
Registry title: Non-Invasive Diagnostic Panel for MASLD in Children With Obesity
Key facts
- Where
- Kayseri, TürkiyeSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers with obesity, to test a blood, ultrasound and gene panel that may detect fatty liver disease (MASLD) without a biopsy.
- Age
- 8 to 18 years
- Sex
- Boys and girls
- Disease stage
- Body mass index at or above the 85th percentile for age and sex. Fatty liver of grade 1 or higher on ultrasound, and/or raised alanine aminotransferase (ALT). At least one cardiometabolic risk factor.
- Earlier treatment
- Must not use liver-harming medicines such as corticosteroids, methotrexate, valproate, amiodarone or tamoxifen.
- Biomarker or test result
- Raised alanine aminotransferase (26 U/L or more for boys, 22 U/L or more for girls) can count, as an alternative to fatty liver on ultrasound.
Main reasons for not taking part
- Viral hepatitis
- Autoimmune liver disease
- Wilson disease, alpha-1 antitrypsin deficiency or hereditary hemochromatosis
- Fasting shorter than 12 hours or active infection (C-reactive protein above 10 mg/L)
- Untreated thyroid disorder, total parenteral nutrition or diabetic ketoacidosis
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 18 years old?
Source: NCT07731360, who can take part
Where in Türkiye
- Kayseri City HospitalKayseri, TürkiyeContact: Agah B ÖZTÜRK, Principal Investigator, Department of Pediatrics, MDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Kayseri City Hospital
- Trial code
- NCT07731360
- Record updated
- 30 July 2026
- Original description
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.Read full original descriptionShow less
A Non-Invasive Diagnostic Panel for MASLD in Children With Obesity: Evaluation of a Multiparametric Biomarker Panel and Genetic Risk Score Using LASSO-Regularized Logistic Regression - The PedMASLD-MultiOmics Pilot Study
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.
Inclusion: 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: Use of hepatotoxic medication, including corticosteroids, methotrexate, valproate, amiodarone, or tamoxifen; Viral hepatitis; Autoimmune liver disease; Wilson disease, alpha-1 antitrypsin deficiency, or hereditary hemochromatosis; 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; Fasting duration shorter than 12 hours; Total parenteral nutrition; Diabetic ketoacidosis; Inability to obtain informed consent.