Understanding health issues related to Down syndrome and obesity
Elucidating Age-related Comorbidity Patterns in Down Syndrome (DS): Prospective Cohort (GO-DS21 Cohort Study)
This study looks at how obesity and related health problems affect people with Down syndrome aged 12 to 45 in France, Spain, and the UK, to see how different factors like age and lifestyle play a role.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 12 Years to 45 Years |
| Sex | All |
| Sponsor | King's College London Academic / other |
| Locations | 3 sites (Paris and 2 other locations) |
| Trial ID | NCT05310552 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the patterns of comorbidities associated with Down syndrome, particularly focusing on obesity and related health conditions. Conducted across three countries (France, Spain, and the UK), it will involve 300 volunteers aged 12 to 45 with a diagnosis of Down syndrome. The study will analyze how age, sex, lifestyle, and stress responses influence obesity and other health issues in these individuals. Participants will be categorized based on their obesity status for a nested case-control analysis.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 12 to 45 years with a confirmed diagnosis of Down syndrome.
Not a fit: Patients with mosaic trisomy 21, partial trisomy 21, or those with significant comorbid conditions that interfere with study participation may not benefit.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of health issues in individuals with Down syndrome, particularly regarding obesity.
How similar studies have performed: While studies on Down syndrome and obesity exist, this specific approach focusing on age-related comorbidity patterns is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Confirmed mosaic trisomy 21, partial trisomy 21, or translocation * 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 * Participation in a medication treatment trial in the last 3 months prior to the study
Where this trial is running
Paris and 2 other locations
- Institute Jérôme Lejeune — Paris, France (Recruiting)
- Institut Hospital del Mar d'Investigacions Mèdiques — Barcelona, Spain (Recruiting)
- King's College London — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Andre Strydom, Prof.
- Email: andre.strydom@kcl.ac.uk
- Phone: 0207 836 5454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.