Actively Recruiting

Age: 12Years - 18Years
All Genders
ID04634643

Mechanisms of Liver Fat Build-up in Obese Youth Studying NAFLD Differences Observational Study Assessing Metabolism and Liver Fat in Hispanic and Non-Hispanic Black Adolescents

Led by Yale University · Updated on 2025-01-27

260

Participants Needed

1

Research Sites

239 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Nonalcoholic fatty liver disease (NAFLD) is a common liver condition in children, especially affecting about 30% of obese youth. This research aims to understand why Hispanic obese youth are more likely to develop NAFLD compared to non-Hispanic Black (NHB) youth, who seem protected despite obesity and insulin resistance. The study explores whether differences in carbohydrate metabolism, including glycolysis, the tricyclic acid cycle, and fat production in the liver, explain the higher NAFLD risk in Hispanic youth and if these changes happen before liver fat builds up. Participants include 30 Hispanic and 30 NHB obese young people, whose carbohydrate metabolism will be measured using advanced techniques that track lactate and other metabolic processes. Additionally, 200 Hispanic obese youth without fatty liver will be followed every 12 months for two years to see if increased glycolysis comes before fat accumulation in the liver. Glucose levels will also be monitored every six months over ten days using continuous glucose monitors to understand if mild glucose changes influence these metabolic processes. During the study, participants will maintain their usual diet and physical activity while researchers assess their liver fat content and metabolism over time. The main outcome measured is lactate synthesis after 60 months. This research paused in 2022 but resumed recruitment in November 2023. Findings may offer new insights into how NAFLD develops in obese youth and inform future treatments.

CONDITIONS

Official Title

Pathogenesis of Pediatric Nonalcoholic Fatty Liver Disease (NAFLD)

Who Can Participate

Age: 12Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Good general health, taking no medication on a chronic basis
  • Age 12 to 18 years, in puberty (Tanner stage II-V)
  • BMI greater than 85th percentile for obese cohort
Not Eligible

You will not qualify if you...

  • Baseline creatinine greater than 1.0 mg
  • Pregnancy
  • Presence of endocrinopathies such as Cushing syndrome
  • Cardiac, pulmonary, or other significant chronic illness
  • Adolescents with psychiatric disorders or substance abuse
  • Monogenic obesity syndromes
  • Use of drugs affecting intrahepatic fat content (e.g., liraglutide, fish oil)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Yale New Haven Hospital

New Haven, Connecticut, United States, 06510

Actively Recruiting

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Research Team

E

Ermena REFUGJATI

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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