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
- Diseases
- Fatty liver disease (MASLD/MASH)
- 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
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University | Atlanta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.