An observational study in Down Syndrome, sponsored by King's College London. Completed at 3 sites in 3 countries. Open to participants aged 12 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by King's College London · Observational
This study is a non-drug, multicenter, prospective cohort study. It will be conducted in 300 volunteers from 12 to 45 years of age (inclusive) with a diagnosis of Down syndrome from 3 countries (France, Spain, United Kingdom (UK)). The basic hypotheses of the study are the following:
The study will be conducted in n= 300 volunteers with DS from 3 countries (France, Spain, UK); equal numbers in 3 age groups (12 - 18 years; 19 - 34 years; 35 - 45 years). The total number of volunteers expected to be included in each country is n = 100.
From the initial cross-sectional cohort, individuals will be selected on the basis of obesity status and invited to participate in a nested case-control study (n = 30 for normal weight DS individuals and n = 30 DS individuals with extreme phenotype). In adults, normal weight is defined as BMI 18.5 to 24.9 and significant obesity as BMI > 35 kg/m2. In children under age 18, the research team will use the International Obesity Task Force (IOTF) curves which are international norms) with IOTF > 30 for obese and IOTF 18.5 - 25 for the normal weight group. The research team will monitor allocation using monthly eCRF recruitment reports for central allocation of recruits to ensure balance between age, sex and BMI between the "cases" and the "controls".
432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.
This study's enrollment of 230 is above the median of 150 across 141 observational studies indexed under Down Syndrome.
Browse Down Syndrome studies →King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.
Counted across the registry records on this site, refreshed daily.
A sample of 300 individuals aged 12-45 years with a diagnosis of Down syndrome will be recruited within the 3 sites.
Participants will be recruited in three age groups stratified by sex:
Exclusion Criteria:
No interventions - observational study
Body Mass Index
Height and weight measurements will be aggregated to arrive at one reported value: Body Mass Index (BMI), in kg/m\^2
Time frame: 1 year
Food Frequency Questionnaire
Average daily nutrient intake
Time frame: 1 year
Short Minnesota Leisure Time Physical Activity Questionnaire
Energy expenditure in 14 days
Time frame: 1 year
Mental health questionnaire
Reiss Screen for Maladaptive Behaviour - composite outcome measure consisting of the following multiple sub-measures: * Aggressive behavior * Autism * Psychosis * Paranoia * Depression (behavioural signs) * Depression (physical signs) * Dependent personality disorder * Avoidant disorder
Time frame: 1 year
Plan to share: No — IPD will be shared within the GO-DS21 Consortium.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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King's College London