Understanding the causes of fatty liver disease in obese youth
Official title: Pathophysiologic Mechanisms Leading to Intrahepatic Fat Accumulation in Obese Youth
Run by Yale University · NCT04634643 · Data updated 2026-11-12
This study is trying to understand why some obese teenagers, especially Hispanic and non-Hispanic Black youth, are more likely to develop fatty liver disease by looking at how their bodies process carbohydrates.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 12 Years to 18 Years |
| Sex | All |
| Enrollment | 260 (estimated) |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Status | Recruiting |
| Started | June 28, 2021 |
| Main results expected | January 30, 2027 |
| Study ends | January 30, 2027 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT04634643 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy adolescents aged 12 to 18 years with a BMI above the 85th percentile.
✕Probably not a fit
Patients with significant chronic illnesses, psychiatric disorders, or those on medications affecting liver fat content may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to uncover the mechanisms behind nonalcoholic fatty liver disease (NAFLD) in obese adolescents, particularly focusing on the differences between Hispanic and non-Hispanic Black youth. NAFLD is prevalent in about 30% of obese youth and can lead to severe liver complications. The study will investigate how metabolic differences in carbohydrate processing may contribute to the varying susceptibility to NAFLD among these populations. Participants will maintain their usual diet and physical activity while data is collected over the course of the study.
Why it matters
Potential benefit: If successful, this research could lead to better understanding and targeted interventions for preventing NAFLD in at-risk youth populations.
How similar studies have gone: While there have been studies on NAFLD, this specific focus on the metabolic differences between Hispanic and non-Hispanic Black youth is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.).
Where it's running
-
Yale New Haven Hospital
New Haven, Connecticut, United States Recruiting
Study contacts
- Principal investigator: Nicola Santoro, MD, PhD — Associate Professor of Pediatrics (Endocrinology)
- Study coordinator: Ermena REFUGJATI
- Email: ermena.refugjati@yale.edu
- Phone: 2032157119
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.