Understanding the causes of fatty liver disease in obese youth

Pathophysiologic Mechanisms Leading to Intrahepatic Fat Accumulation in Obese Youth

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
• Enrollment: 260 (estimated)
• Ages: 12 Years to 18 Years
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT04634643 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are healthy adolescents aged 12 to 18 years with a BMI above the 85th percentile.

Not a fit: Patients with significant chronic illnesses, psychiatric disorders, or those on medications affecting liver fat content may not benefit from this 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 performed: While there have been studies on NAFLD, this specific focus on the metabolic differences between Hispanic and non-Hispanic Black youth is relatively novel.

Eligibility 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 this trial is running

New Haven, Connecticut

• 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

Conditions NAFLD