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NCT05292352Terminated

Prevention of NAFLD in Hispanic Children

Prevention of Non-alcoholic Fatty Liver Disease (NAFLD) in Hispanic Children

Source: ClinicalTrials.gov · Last updated 2 Jun 2026

Reason given: Study was terminated due to a lack of funding. Data collection was completed for 12-month outcomes; however, funding limitations prevented follow-up for longer timeframes, and some outcomes were not fully collected.

Brief summary (registry, in English)

This is a 2 year clinical trial testing an intensive intervention to reduce dietary sugars as a means to prevent non-alcoholic fatty liver disease (NAFLD) in pre-pubertal Hispanic children.

Status (registry)
Terminated
Study type
Interventional
Enrollment
103 (actual)
First submitted
15 Mar 2022
Start date
6 Apr 2022
Primary completion date
31 Mar 2026
Lead sponsor
Emory University
NCT number
NCT05292352

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Implanted metal or other implant (braces ok), or claustrophobia or other reason that contraindicates MRI
  • Current or previous participation in a weight loss program or obesity treatment program or clinic
  • Recipient of a liver transplant
  • Chronic use (in the last year) of medications known to cause NAFLD or fatty liver (TPN, amiodarone, chronic oral steroids, etc.)
  • Participants who are currently enrolled in a clinical trial or have received an investigational product within the last 60 days

Other illness

  • Known diagnosis of chronic liver disease other than NAFLD and "fatty liver"
  • History of significant depression
  • Cancer or history of cancer
  • Intellectual disability or major psychiatric disorder limiting informed assent
  • At risk for eating disorder by screening instrument
  • Participants who are not able or willing to comply with the diet protocol or have any other condition or circumstance that would impede compliance or hinder completion of the study in the opinion of the investigator

Lab values

  • Type 2 diabetes (Hemoglobin A1c > 6.4% on screening labs or chronic diagnosis)

Other

  • Plans to move within the next 12 months
  • Children who spend more than 1 night per week consistently in another household

Who the study is looking for

  • At least one parent or the child self-identifies as Hispanic or Latino.
  • BMI ≥ 50th percentile for age and sex.
  • Age ≥ 6 years and ≤ 9 years
  • Tanner stage 1 by self and/or parental report
  • Normal ALT on screening labs (≤23 IU for girls, ≤26 IU for boys)
  • Written informed consent from parent or legal guardian, assent from child

Age in the registry: 6 years to 9 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Emory UniversityAtlantaUnited StatesUnknown status

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.