Obesity PreventionLiverTyNCT06888570
Relationship Between Eating Patterns, Body Composition and the Detection of Fatty Liver in Children and Adolescents With Trisomy 21: LiverTy Project
An observational study of Obesity Prevention and Pediatric Obesity, run by IMDEA Food at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 5 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity Prevention, Pediatric Obesity, Trisomy 21
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2025to 30 Jul 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Not meeting the inclusion criteria
- Have previous liver pathology.
- Be under any medical treatment that
- Modify composition parameters Body: GLP-1 analogues and derivatives.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the detailed description
- 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
- 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.
- 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
- 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.
- 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.
- Conditions
- Obesity Prevention, Pediatric Obesity, Trisomy 21, Down Syndrome (Trisomy 21), Elastography, Nutrition Assessment
- Being tested
- To evaluate fat liver content in the cases/controls population.
- Keywords
- Fibroscan, Fatty liver disease, Body composition, Trisomy 21, Down Syndrome, KIDMED questionnaire, 24-hour dietary recall, Non-invasive liver assessment, Non Alcoholic Fatty Liver Diseases, Obesity prevention, Children, Adolescents
- Medical subject headings
- Pediatric Obesity, Down Syndrome, Liver Diseases, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To evaluate fat liver content in the cases/controls population.Other
The studied population includes participants aged 5-22 years old with/without T21 Down Syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Case group. | Children and adolescents (ages 5-22) with Down syndrome (T21) who may have or not have NAFLD. Receives: Other: To evaluate fat liver content in the cases/controls population. | |
| Control group. | Children and adolescents (ages 5-22) without Down syndrome (T21) who may have or not have NAFLD. Receives: Other: To evaluate fat liver content in the cases/controls population. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months.
Secondary outcomes (9)
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.
Measured: 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.
Measured: 3 months.
Body Mass Index.
Body Mass Index (kg/m*2) will be calculated with the body weight and height.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Mar 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Obesity PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- IMDEA Food
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorena Lopez Lora, IMDEA Food
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888570
- Sponsor's protocol ID
- IMD: PI-070
- Acronym
- LiverTy
- Status last verified
- Apr 2025
- First submitted
- 28 Feb 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Relevant data obtained on the relationship of fatty liver in the studied population
Publications
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.
PubMed 31146796Hewawitharana 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.
PubMed 30482218Arsoy 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.
PubMed 38635340Castera 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.
PubMed 30660725Hielscher 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.
PubMed 37738668Vos 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 Pediatr Gastroenterol Nutr. 2017 Feb;64(2):319-334. doi: 10.1097/MPG.0000000000001482.
PubMed 28107283Goldner 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.
PubMed 32201176Bertapelli 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.
PubMed 27448331Pecoraro L, Ferron E, Solfa M, Mirandola M, Lauriola S, Piacentini G, Pietrobelli A. Body composition and laboratory parameters in children with down syndrome: The DONUT study. Clin Nutr ESPEN. 2023 Oct;57:253-257. doi: 10.1016/j.clnesp.2023.07.003. Epub 2023 Jul 10.
PubMed 37739665
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06888570
- Acronym / sponsor ID
- LiverTy / IMD: PI-070
- Conditions
- Obesity Prevention, Pediatric Obesity, Trisomy 21, Down Syndrome (Trisomy 21), Elastography, Nutrition Assessment
- Keywords
- Fibroscan, Fatty liver disease, Body composition, Trisomy 21, Down Syndrome, KIDMED questionnaire, 24-hour dietary recall, Non-invasive liver assessment
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- IMDEA FoodUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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
- 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.
- 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
- 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group. | – | Other: To evaluate fat liver content in the cases/controls population.Children and adolescents (ages 5-22) with Down syndrome (T21) who may have or not have NAFLD. |
| Control group. | – | 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. |
Who may qualify
- Ages
- 5 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Not meeting the inclusion criteria
- Have previous liver pathology.
- Be under any medical treatment that
- Modify composition parameters Body: GLP-1 analogues and derivatives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Case group., Control group. |
Primary outcome
Liver fat content.
Time frame: 3 months.
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.
9 secondary outcomes
Body weight.
Time frame: 3 months.
Height.
Time frame: 3 months.
Body Mass Index.
Time frame: 3 months.
Waist circumference.
Time frame: 3 months.
Adipose tissue (%).
Time frame: 3 months.
Visceral fat index.
Time frame: 3 months.
Muscle mass.
Time frame: 3 months.
24-hour dietary quality evaluation.
Time frame: 3 months.
Mediterranean diet adherence.
Time frame: 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Background: PubMed 31146796Altavilla 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.
- Background: PubMed 30482218Hewawitharana 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.
- Background: PubMed 38635340Arsoy 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.
- Background: PubMed 30660725Castera 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.
- Background: PubMed 37738668Hielscher 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.
- Background: PubMed 28107283Vos 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 Pediatr Gastroenterol Nutr. 2017 Feb;64(2):319-334. doi: 10.1097/MPG.0000000000001482.
- Background: PubMed 32201176Goldner 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.
- Background: PubMed 27448331Bertapelli 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.
- Background: PubMed 37739665Pecoraro L, Ferron E, Solfa M, Mirandola M, Lauriola S, Piacentini G, Pietrobelli A. Body composition and laboratory parameters in children with down syndrome: The DONUT study. Clin Nutr ESPEN. 2023 Oct;57:253-257. doi: 10.1016/j.clnesp.2023.07.003. Epub 2023 Jul 10.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Relevant data obtained on the relationship of fatty liver in the studied population
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity Prevention and Pediatric Obesity, run by IMDEA Food at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver fat content. (time frame: 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06888570, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.