NCT04634643

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

June 28, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

4.6 years

First QC Date

November 17, 2020

Last Update Submit

January 24, 2025

Conditions

NAFLD

Outcome Measures

Primary Outcomes (1)

  • Lactate synthesis

    lactate synthesis will be measured during an oral glucose tolerance test by measuring lactate. Synthetic rates will be measured by using a mathematical model.

    60 months

Interventions

Usual diet and physical activityOTHER

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

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Hispanics and NHB youth with and without NAFLD

You may qualify if:

  • 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;

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Nicola Santoro, MD, PhD

    Associate Professor of Pediatrics (Endocrinology)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ermena REFUGJATI

CONTACT

2032157119ermena.refugjati@yale.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2020

First Posted

November 18, 2020

Study Start

June 28, 2021

Primary Completion

January 30, 2026

Study Completion

January 30, 2026

Last Updated

January 27, 2025

Record last verified: 2025-01

Locations

US(1)