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NCT05310552: GO-DS21

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

Completed Last updated 9 July 2025
What this trial tests

trial testing No interventions - observational study in Down Syndrome in 230 participants. Completed in 30 June 2025.

Timeline
10 June 2021
Primary endpoint
30 November 2024
30 June 2025

Quick facts

Lead sponsorKing's College London
StatusCompleted
Study typeOBSERVATIONAL
Enrollment230
Start date10 June 2021
Primary completion30 November 2024
Estimated completion30 June 2025
Sites3 locations across France, United Kingdom, Spain

Drugs / interventions tested

Conditions studied

Sponsor

King's College London

Who can join

Adults 12 to 45, any sex, with Down Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Dietary Patterns and Lifestyle Factors as Determinants of Body Mass Index and Body Composition in Individuals with Down Syndrome-A Study Across Three Clinical Sites.
    Gomis-González M, Boronat A, Langohr K, Bianchi LA, et al · · 2026 · PMID 41829952 · DOI 10.3390/nu18050779

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Other recruiting trials for Down Syndrome

Currently open trials in the same condition.

Other King's College London trials

Trials by the same sponsor.

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