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Checking Liver Fat and Eating Habits in Children With Down Syndrome

Checks liver fat in children with Down syndrome using scans and diet questionnaires.

Plain-language title generated from the registry record
Registry title: Relationship Between Eating Patterns, Body Composition and the Detection of Fatty Liver in Children and Adolescents With Trisomy 21: LiverTy Project

Key facts

Where
Madrid, SpainSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 5 and 22 years old?

Source: NCT06888570, who can take part

Where in Spain

  • Fundación Jerome LejeuneMadrid, SpainNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
IMDEA Food
Trial code
NCT06888570
Record updated
2 May 2025
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: Have previous liver pathology; Not meeting the inclusion criteria; Be under any medical treatment that; Modify composition parameters Body: GLP-1 analogues and derivatives.

ClinicalTrials.gov NCT06888570