NCT05310552Completed
Elucidating Age-related Comorbidity Patterns in Down Syndrome (DS)
Elucidating Age-related Comorbidity Patterns in Down Syndrome (DS): Prospective Cohort (GO-DS21 Cohort Study)
Source: ClinicalTrials.gov · Last updated 9 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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: 1. Diseases (and comorbidity) arise from one or more biological networks perturbed by the genetic disorder (trisomy 21) through interaction with environmental risks factors and epigenetic changes. 2. Health comorbidity patterns in DS individuals (particularly of obesity and related conditions) will likely vary by age and sex. 3. Obesity comorbidity patterns will relate to variation in factors including lifestyle, stress-response, severity of intellectual disability (ID) and variation in cognitive domains such as executive functioning. 4. Stress responses, as measured with cortisol concentrations, will differentiate individuals with DS who are obese and those who are not. Extremes in phenotype (Obese vs. Non-obese) will be related to differences in the metabolomic, transcriptomic, and microbiome concentrations.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 230 (actual)
- First submitted
- 10 Feb 2022
- Start date
- 10 Jun 2021
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- King's College London
- Diseases
- Obesity
- NCT number
- NCT05310552
What you commit to
- Study type: Observational
- Participants enrolled: 230
- From 10 Jun 2021 to the primary completion date, 30 Nov 2024
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in a medication treatment trial in the last 3 months prior to the study
Other illness
- Comorbid conditions - Participation is allowed as long as the condition(s) are considered stable and it do not interfere with the participation of the study
- Subjects with evidence of dementia or meeting clinical diagnoses for dementia
Other
- Confirmed mosaic trisomy 21, partial trisomy 21, or translocation
Who the study is looking for
- Males and females aged 12 to 45 years
- With established genetic diagnosis of Down syndrome (full trisomy 21; based on karyotype results - not exclusion if not available but will need to confirm karyotype if not done previously)
- Availability of parent/caregiver to accompany the subject to clinical visits and to be willing to give written informed consent, when necessary
Age in the registry: 12 years to 45 years · Sex: All
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Hospital del Mar d'Investigacions Mèdiques Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Institute Jérôme Lejeune Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| King's College London Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.