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NCT06888570Enrolling by invitation

Relationship Between Eating Patterns, Body Composition and the Detection of Fatty Liver in Children and Adolescents With Trisomy 21: LiverTy Project

Childhood Obesity is a Global Health Issue, Especially in Children With Trisomy 21 (T21), Who Face Higher Risks of Non-alcoholic Fatty Liver Disease (NAFLD). Early Detection Using Non-invasive Tools Like Liver Elastography is Key. Evaluating Dietary Patterns With the 24-hour Food Recall and KIDMED Helps Guide Personalized Interventions

Source: ClinicalTrials.gov · Last updated 2 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Childhood obesity is a growing public health issue affecting millions of children worldwide, increasing the risk of metabolic and cardiovascular diseases in adulthood. This problem is particularly concerning in children and adolescents with Down syndrome (trisomy 21, T21), who have a higher predisposition to fat accumulation due to genetic, metabolic, and behavioral factors. However, assessing their nutritional status and body composition is challenging, as conventional tools such as body mass index (BMI) may not accurately reflect adiposity in this population. One of the most severe risks associated with obesity in children with T21 is non-alcoholic fatty liver disease (NAFLD). This condition is characterized by fat accumulation in the liver without significant alcohol consumption and is closely linked to insulin resistance, dyslipidemia, and pro-inflammatory states. If not detected early, NAFLD can progress to more severe liver diseases such as fibrosis or cirrhosis. In individuals with T21, the prevalence of NAFLD may be underestimated due to the difficulty in properly assessing body composition and metabolism. Since NAFLD diagnosis traditionally requires invasive procedures such as liver biopsy, this study proposes using non-invasive techniques, such as liver elastography, to assess liver health in children and adolescents with T21. Additionally, dietary habits will be analyzed using standardized tools to establish the relationship between nutrition, body composition, and NAFLD risk in this population. Study Hypothesis: The main hypothesis is that obesity and inadequate dietary patterns increase the risk of NAFLD in our participants with T21. The investigators also believe that liver elastography will enable the early detection of fat accumulation in the liver and other signs of liver disease, facilitating timely intervention. Study Objectives: The primary objective of this study is to evaluate the presence and severity of NAFLD in children and adolescents with T21 using non-invasive diagnostic techniques and nutritional assessment methods. Specifically, the study will analyze: * Liver health: Measurement of liver fat and stiffness using elastography. Body composition: Anthropometric evaluation and adiposity analysis. Dietary habits: 24-hour food recall and KIDMED questionnaire to assess adherence to the Mediterranean diet. * Relationship between obesity and NAFLD: Identification of metabolic and behavioral risk factors.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
34 (estimated)
First submitted
28 Feb 2025
Start date
1 Mar 2025
Primary completion date
30 Jun 2025
Lead sponsor
IMDEA Food
NCT number
NCT06888570

What you commit to

  • Study type: Observational
  • Planned participants: 34
  • From 1 Mar 2025 to the primary completion date, 30 Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

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

Prior treatment

  • Have previous liver pathology.

Other

  • Not meeting the inclusion criteria
  • Be under any medical treatment that
  • Modify composition parameters Body: GLP-1 analogues and derivatives.

Who the study is looking for

  • Children (5-10 years), and adolescents (11-19) andyoung adults (20-22 years) of bothSexes
  • 5 to 22 years old
  • Diagnosis of trisomy 21 or other intellectual disability of genetic origin for the group of the cases.
  • BMI: 17-40 Kg/m2
  • Signing of the informed consent by the parents or guardians.

Age in the registry: 5 years to 22 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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SiteCityCountrySite status
Fundación Jerome Lejeune
Coordinator of this site? Confirm its status
MadridSpainUnknown status

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