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A needle-free way to detect fatty liver in kids? a new study puts a multi-test panel to the test.

NCT ID NCT07731360

Diagnosis Sponsor: Kayseri City Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 28, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study tests whether a combination of blood markers, ultrasound, and genetic information can accurately diagnose metabolic dysfunction-associated steatotic liver disease (MASLD) in children aged 8 to 18 with obesity. Each child provides a blood sample, undergoes a liver ultrasound, and gives a cheek swab for genetic testing. The goal is to see if this non-invasive panel can reliably identify MASLD without a liver biopsy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple, needle-free way to diagnose fatty liver disease in children with obesity, avoiding the need for a liver biopsy.
What could go wrong
This is a small, early pilot study. The diagnostic panel may not prove accurate enough to replace current methods, and results may not apply to all children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

8 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome Genetic Risk Score metabolic dysfunction-associated steatotic liver disease metabolic syndrome X obesity disorder Pediatric Obesity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insulin resistance syndrome Metabolic dysfunction-associated steatotic liver disease Pediatric obesity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kayseri City Hospital

    Kayseri, 38080, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.