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Elucidating Age-related Comorbidity Patterns in Down Syndrome (DS)

NCT05310552 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 230

Last updated 2025-07-09

No results posted yet for this study

Summary

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.

Conditions

  • Down Syndrome

Interventions

OTHER

No interventions - observational study

No interventions - observational study

Sponsors & Collaborators

  • Fondation Jérôme Lejeune

    collaborator OTHER

  • Parc de Salut Mar

    collaborator OTHER

  • King's College London

    lead OTHER

Eligibility

Min Age
12 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-10
Primary Completion
2024-11-30
Completion
2025-06-30

Countries

  • France
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05310552 on ClinicalTrials.gov