NCT06888570: LiverTy

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

ENROLLING BY INVITATION Last updated 2 May 2025

What this trial tests

trial testing To evaluate fat liver content in the cases/controls population. in Obesity Prevention in 34 participants. Enrolling by invitation.

Timeline

1 March 2025

Primary endpoint
30 June 2025

30 July 2025

Quick facts

Lead sponsor	IMDEA Food
Status	ENROLLING BY INVITATION
Study type	OBSERVATIONAL
Enrollment	34
Start date	1 March 2025
Primary completion	30 June 2025
Estimated completion	30 July 2025
Sites	1 location across Spain

Drugs / interventions tested

• To evaluate fat liver content in the cases/controls population.

Conditions studied

• Obesity Prevention — all drugs for Obesity Prevention →
• Pediatric Obesity — all drugs for Pediatric Obesity →
• Trisomy 21 — all drugs for Trisomy 21 →
• Down Syndrome (Trisomy 21) — all drugs for Down Syndrome (Trisomy 21) →

Sponsor

IMDEA Food

Who can join

Adults 5 to 22, any sex, with Obesity Prevention or Pediatric Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.