An observational study in Obesity Prevention, Pediatric Obesity and Trisomy 21, sponsored by IMDEA Food. Enrolling by invitation at 1 site in Spain. Open to participants aged 5 Years to 22 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-02.
Sponsored by IMDEA Food · Observational
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:
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.
Registration and Evaluation Procedures
2.1 Clinical Assessments
Adipose tissue %, muscle mass (kg) and visceral fat index.
2.2. Nutritional Evaluation:
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.
Quality Assurance Plan
Electronic data management system with automatic validations to prevent data entry errors.
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.
Statistical Analysis Plan
Ethical and Safety Considerations
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.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's planned enrollment of 34 is below the median of 180 across 235 observational studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →IMDEA Food is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants will be selected who are patients at the Jerome Lejeune Foundation center or students in special education centers who wish to participate. For the control group, dissemination will be carried out among workers with children of the required age range.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children and adolescents (ages 5-22) with Down syndrome (T21) who may have or not have NAFLD.
Other: To evaluate fat liver content in the cases/controls population.
Children and adolescents (ages 5-22) without Down syndrome (T21) who may have or not have NAFLD.
Other: 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.
Liver fat content.
To estimate liver fat content with hepatic elastography (FibroScan), CAP measurement will be used. Control population CAP value would range between 160-184 db/m and cases ≥ 184 db/m.
Time frame: 3 months.
Body weight.
Body weight (kg) will be assessed with a calibrated scale with the purpose of obtaining descriptive data of both populations, cases and controls.
Time frame: 3 months.
Height.
Height (cm) will be assessed with a calibrated stadiometer with the purpose of obtaining descriptive data of both populations, cases and controls.
Time frame: 3 months.
Body Mass Index.
Body Mass Index (kg/m\*2) will be calculated with the body weight and height.
Time frame: 3 months.
Waist circumference.
Waist circumference (cm) will be assessed with a measuring tape with the purpose of obtaining descriptive data of both populations, cases and controls.
Time frame: 3 months.
Adipose tissue (%).
Adipose tissue (%) will be estimated with bioimpedance with a calibrated TANITA with the purpose of obtaining descriptive data of both populations, cases and controls.
Time frame: 3 months.
Visceral fat index.
Visceral fat index will be estimated with bioimpedance with a calibrated TANITA with the purpose of obtaining descriptive data of both populations, cases and controls.
Time frame: 3 months.
Muscle mass.
Muscle mass (kg) will be estimated with bioimpedance with a calibrated TANITA with the purpose of obtaining descriptive data of both populations, cases and controls.
Time frame: 3 months.
24-hour dietary quality evaluation.
24-hour dietary quality will be assessed with a validated 24-h recall food questionnaire in both populations, cases and controls.
Time frame: 3 months.
Mediterranean diet adherence.
Mediterranean diet adherence will be assessed with a validated mediterranean food questionnaire for pediatric population (KIDMED) in both, cases and controls.
Time frame: 3 months.
Plan to share: Undecided — Relevant data obtained on the relationship of fatty liver in the studied population
Started Mar 2025 (actual). Primary completion is estimated for Jun 2025, 3 months after the start.
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