NCT04634643 Pathogenesis of Pediatric Nonalcoholic Fatty Liver Disease (NAFLD)
| NCT ID | NCT04634643 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | NAFLD |
| Study Type | OBSERVATIONAL |
| Enrollment | 260 participants |
| Start Date | 2021-06-28 |
| Primary Completion | 2026-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 260 participants in total. It began in 2021-06-28 with a primary completion date of 2026-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main aim of the study is to discover the mechanisms underlying the pathophysiology of NAFLD in obese youth.
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.).
Contact & Investigator
Nicola Santoro, MD, PhD
PRINCIPAL INVESTIGATOR
Associate Professor of Pediatrics (Endocrinology)
Frequently Asked Questions
Who can join the NCT04634643 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying NAFLD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04634643 currently recruiting?
Yes, NCT04634643 is actively recruiting participants. Contact the research team at ermena.refugjati@yale.edu for enrollment information.
Where is the NCT04634643 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT04634643 clinical trial?
NCT04634643 is sponsored by Yale University. The principal investigator is Nicola Santoro, MD, PhD at Associate Professor of Pediatrics (Endocrinology). The trial plans to enroll 260 participants.