Recruiting

Observational Study

Sponsor:

Yale University

Code:

NCT04634643

Conditions

NAFLD

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

Usual diet and physical activity

Study Details

Brief summary:

The main aim of the study is to discover the mechanisms underlying the pathophysiology of NAFLD in obese youth.

Conditions

NAFLD

Study ID

NCT04634643

Start date

Jun 28, 2021

Status verified date

Jul, 2026

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

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.).

Study Design

Enrollment

260 participants

Anticipated

Interventions and Outcome Measures

Interventions

Usual diet and physical activity

Patients will be followed up to assess the effect of the usual diet and physical activity on development of NAFLD

Primary outcome measure

  • Lactate synthesis [ Time Frame: 60 months ]

Central Contacts and Locations

Central contacts

Ermena REFUGJATI

2032157119ermena.refugjati@yale.edu

Locations

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Ermena Refugjati

203-215-7119ermena.refugjati@yale.edu

Principal Investigator:

Nicola Santoro, MD, PhD

More Information

Sponsor

Yale University

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-07-30.