Non-Invasive Diagnostic Panel for MASLD in Children With Obesity

NCT07731360 | Not Yet Recruiting

• 2 other identifiers: Etik C.D.No:1009(Kayseri CH)TUSEB-2026-A4-U-55859
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Obesity; Metabolic Dysfunction-Associated Steatotic Liver Disease; Insulin Resistance Syndrome

Keywords

MASLD; NAFLD; Pediatric Obesity; Non-Invasive Diagnosis; Cytokeratin-18; FGF21; RBP4; IGFBP7; Shear Wave Elastography; PNPLA3; Polygenic Risk Score; LASSO; Diagnostic Accuracy

Outcome Measures

Primary Outcomes (1)

• Diagnostic Performance of the LASSO-Regularized Multi-Parameter Panel for MASLD

  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.

  Through study completion, an average of 12 months

Secondary Outcomes (3)

• Comparative Discrimination of the Panel Versus Alanine Aminotransferase Alone and Ultrasonography Alone

  Through study completion, an average of 12 months

• Serum Biomarker Concentrations in MASLD-Positive Versus MASLD-Negative Children With Obesity

  Day 1 (single study visit)

• Incremental Discriminative Value of Serum IGFBP7

  Through study completion, an average of 12 months

Study Arms (2)

Group 1 MASLD-Positive

MASLD-Positive - Children with obesity classified as having MASLD by the composite reference standard (ultrasonographic steatosis grading plus cardiometabolic risk factor criteria). All candidate index tests are performed.

Diagnostic Test: Non-Invasive Multi-Parameter Diagnostic Panel

Group 2 MASLD-Negative

MASLD-Negative - Children with obesity not meeting the composite reference standard for MASLD. All candidate index tests are performed.

Diagnostic Test: Non-Invasive Multi-Parameter Diagnostic Panel

Interventions

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.

Group 1 MASLD-Positive; Group 2 MASLD-Negative

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 8 to 18 years with a body mass index at or above the 85th percentile for age and sex, screened consecutively in the pediatric endocrinology outpatient clinic of a single tertiary center in Kayseri, Türkiye. Participants are enrolled prospectively using consecutive non-probability sampling and are classified as MASLD-positive or MASLD-negative according to a composite reference standard.

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.

Sponsors & Collaborators

• Kayseri City Hospital: lead
• Presidency of the Health Institutes of Türkiye: collaborator

Study Sites (1)

Kayseri City Hospital

Kayseri, 38080, Turkey (Türkiye)

Location

Related Publications (40)

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Biospecimen

Retention: SAMPLES WITH DNA

Serum and plasma aliquots stored at -80 °C for batched biomarker analysis; whole blood and isolated DNA for genotyping of three MASLD-associated variants.

MeSH Terms

Conditions

Pediatric Obesity; Metabolic Syndrome; Non-alcoholic Fatty Liver Disease; Genetic Risk Score

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Genetic Predisposition to Disease; Disease Susceptibility; Disease Attributes; Pathologic Processes

Study Officials

• Agah B ÖZTÜRK, MD

  Kayseri City Hospital, Kayseri, Türkiye

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agah Bahadır Öztürk, MD

CONTACT

Türkiye; dr-agahoz@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Pediatrics

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 28, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available after publication of the main results and will remain available for 5 years thereafter, upon reasonable request to the principal investigator
• Access Criteria: Qualified researchers may request access by contacting the principal investigator. Requests will be evaluated for scientific merit and for consistency with the original ethics approval and the scope of participant consent. A data-use agreement must be executed before de-identified data are released.

Locations

TU (1)