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

Официальное название

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

Обзор

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.

Подробное описание

1. Study Design

This is an observational cross-sectional study in which participants with T21, with and without obesity, will be evaluated without direct therapeutic intervention. 2. Registration and Evaluation Procedures

2.1 Clinical Assessments * Liver Elastography: Assessment of liver stiffness using FibroScan. Hepatic elastography is a non-invasive imaging technique used to assess liver stiffness and fat content, which correlates with liver fibrosis. It is particularly useful in pediatric populations for evaluating liver diseases such as non-alcoholic fatty liver disease (NAFLD), viral hepatitis, and other chronic liver conditions. FibroScan measures ultrasound signal attenuation due to liver fat content. Higher values (db/m) indicate more fat deposition. * Anthropometric Measurements: Weight, height, body mass index (BMI), abdominal circumference. * Body composition parameters measured by bioimpedance:

Adipose tissue %, muscle mass (kg) and visceral fat index.

2.2. Nutritional Evaluation: * 24-hour dietary recall. To estimate nutrient consumption, dietary intake from the 24-hour dietary recall will be converted given the use of nutritional composition tables and validated food composition software (DIAL). * KIDMED questionnaire for adherence to the Mediterranean diet.

The KIDMED (Mediterranean Diet Quality Index) questionnaire is a widely used tool to assess adherence to the Mediterranean diet among children and adolescents. It consists of 16 items that evaluate various dietary habits. Each item is scored as follows:

Positive connotation items (reflecting healthy Mediterranean dietary habits): Each receives a score of +1.

Negative connotation items (indicating departure from Mediterranean dietary principles): Each receives a score of -1.

The total KIDMED score ranges from -4 to 12. Based on the total score, adherence to the Mediterranean diet is categorized into three levels:

High adherence: Scores of ≥8. Medium adherence: Scores between 4 and 7. Low adherence: Scores of ≤3. 3. Quality Assurance Plan

Electronic data management system with automatic validations to prevent data entry errors. 4. Sample Size Evaluation

It is estimated that a sample of 17 participants with T21 and 17 participants in the control group reaches 80% statistical power in detecting significant differences in the detection of fatty liver. 5. Statistical Analysis Plan

* Descriptive statistics will be used to characterize the sample. * Correlation tests and logistic regression will be performed to assess the relationship between NAFLD and metabolic factors. * Analysis of variance (ANOVA) will be used to compare parameters among subgroups. 6. Ethical and Safety Considerations

* Approval from the Research Ethics Committee. * Data management in compliance with the General Data Protection Regulation (GDPR).

This protocol will allow us to evaluate the relationship between obesity, dietary patterns, and NAFLD in children with T21, providing key information for future preventive strategies.

Вмешательства

• Другое To evaluate fat liver content in the cases/controls population.
  The studied population includes participants aged 5-22 years old with/without T21 Down Syndrome.

Первичные конечные точки

• Liver fat content. [Срок оценки: 3 months.]

Вторичные конечные точки (9)

• Body weight. [Срок оценки: 3 months.]
• Height. [Срок оценки: 3 months.]
• Body Mass Index. [Срок оценки: 3 months.]
• Waist circumference. [Срок оценки: 3 months.]
• Adipose tissue (%). [Срок оценки: 3 months.]
• Visceral fat index. [Срок оценки: 3 months.]
• Muscle mass. [Срок оценки: 3 months.]
• 24-hour dietary quality evaluation. [Срок оценки: 3 months.]
• Mediterranean diet adherence. [Срок оценки: 3 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Испания · 1 центр

• Fundación Jerome Lejeune — Madrid

Публикации

• Altavilla C, Caballero-Perez P. An update of the KIDMED questionnaire, a Mediterranean Diet Quality Index in children and adolescents. Public Health Nutr. 2019 Oct;22(14):2543-2547. doi: 10.1017/S1368980019001058. Epub 2019 May 31. PMID 31146796
• Hewawitharana SC, Thompson FE, Loria CM, Strauss W, Nagaraja J, Ritchie L, Webb KL. Comparison of the NHANES dietary screener questionnaire to the Automated Self-Administered 24-Hour Recall for Children in the Healthy Communities Study. Nutr J. 2018 Nov 27;17(1):111. doi: 10.1186/s12937-018-0415-1. PMID 30482218
• Arsoy HA, Kara O, Keskin M. The evaluation of non-alcoholic fatty liver disease in children with obesity with vibration-controlled transient elastography. J Clin Ultrasound. 2024 Jul-Aug;52(6):723-730. doi: 10.1002/jcu.23698. Epub 2024 Apr 18. PMID 38635340
• Castera L, Friedrich-Rust M, Loomba R. Noninvasive Assessment of Liver Disease in Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. 2019 Apr;156(5):1264-1281.e4. doi: 10.1053/j.gastro.2018.12.036. Epub 2019 Jan 18. PMID 30660725
• Hielscher L, Irvine K, Ludlow AK, Rogers S, Mengoni SE. A Scoping Review of the Complementary Feeding Practices and Early Eating Experiences of Children With Down Syndrome. J Pediatr Psychol. 2023 Nov 16;48(11):914-930. doi: 10.1093/jpepsy/jsad060. PMID 37738668
• Vos MB, Abrams SH, Barlow SE, Caprio S, Daniels SR, Kohli R, Mouzaki M, Sathya P, Schwimmer JB, Sundaram SS, Xanthakos SA. NASPGHAN Clinical Practice Guideline for the Diagnosis and Treatment of Nonalcoholic Fatty Liver Disease in Children: Recommendations from the Expert Committee on NAFLD (ECON) and the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN). J PMID 28107283
• Goldner D, Lavine JE. Nonalcoholic Fatty Liver Disease in Children: Unique Considerations and Challenges. Gastroenterology. 2020 May;158(7):1967-1983.e1. doi: 10.1053/j.gastro.2020.01.048. Epub 2020 Mar 20. PMID 32201176
• Bertapelli F, Pitetti K, Agiovlasitis S, Guerra-Junior G. Overweight and obesity in children and adolescents with Down syndrome-prevalence, determinants, consequences, and interventions: A literature review. Res Dev Disabil. 2016 Oct;57:181-92. doi: 10.1016/j.ridd.2016.06.018. Epub 2016 Jul 19. PMID 27448331

Идентификаторы

NCT: NCT06888570 · IMD: PI-070

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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