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Understanding Pediatric Nonalcoholic Fatty Liver Disease (NAFLD)

This observational study aims to understand why some obese teenagers develop Nonalcoholic Fatty Liver Disease (NAFLD), a common liver condition. Researchers will follow participants to see how their usual diet and physical activity affect the development of NAFLD. The study is looking for 260 participants between 12 and 18 years old who are in good general health and have a high Body Mass Index (BMI). The main goal is to measure lactate synthesis (a chemical produced during metabolism) after 60 months to learn more about the disease. The study is particularly interested in understanding differences in how Hispanic and non-Hispanic Black youth process carbohydrates, which might explain why NAFLD is more common in some groups.

Study design
This is an observational study involving 260 participants. It is not testing a new treatment but rather observing participants' usual diet and physical activity.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 60 months to measure lactate synthesis.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04634643

Pathogenesis of Pediatric Nonalcoholic Fatty Liver Disease (NAFLD)

Recruiting
Not specifiedAges 12–18Observational
Yale University
~260 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Usual diet and physical activity

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Lactate synthesis
Measured over 60 months

Conditions

NAFLD

Explore related trials

Nonalcoholic Fatty Liver Disease

NCT04634643

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Yale New Haven Hospital

    New Haven, Connecticutstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Nicola Santoro, MD, PhD · PRINCIPAL_INVESTIGATOR · Associate Professor of Pediatrics (Endocrinology)

Who to contact

Ermena REFUGJATI
[email protected]
2032157119
Email the study team

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Eligibility criteria

Inclusion

Good general health, taking no medication on a chronic basis;
age 12 to 18 years, in puberty (girls and boys: Tanner stage II-V);
BMI \>85th for obese cohort;

Exclusion

Baseline creatinine \>1.0 mg; pregnancy;
the presence of endocrinopathies (e.g. Cushing syndrome);
cardiac or pulmonary or other significant chronic illness;
adolescents with a psychiatric disorder or with substance abuse;
monogenic obesity syndromes;
use of drugs affecting intrahepatic fat content (e.g.; liraglutide, fish oil, etc.).

What this trial measures

  • Lactate synthesis60 months

    lactate synthesis will be measured during an oral glucose tolerance test by measuring lactate. Synthetic rates will be measured by using a mathematical model.