How the sympathetic (fight-or-flight) system works in adults with Down syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional study will provoke sympathetic activation in adults with Down syndrome using standardized stressors including exercise, cold exposure, pain stimuli, fear responses, and caffeine. Investigators will record beat-to-beat heart rate and blood pressure, collect blood samples for catecholamine measurements, and use catheter-based monitoring when needed. Eligible participants are adults 18–50 years old without recent cardiovascular, pulmonary, inflammatory, or metabolic disease and must tolerate repeated blood draws and procedures after a 12-hour fast. Data will be compared to expected physiological responses to characterize whether sympathetic responses are blunted or otherwise different in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18-50 yrs old and apparently healthy individuals
* Ability to understand the study and give assent to participate
* Has a study partner who can attend all visits for the individuals with DS, and answer questionnaires, provide consent when necessary
* Corrected or non-existent congenital heart disease
* Euthyroid or on stable thyroid medication dose for at least 6 months
* Free from cardiovascular, pulmonary, inflammatory, or metabolic disease in the past 6 months that would prevent participation in study procedures
* BMI \<45kg/m2
* Ability to tolerate repeated blood draws / catheter placement

Exclusion Criteria:

* Hypertension (resting systolic blood pressure \[SBP\] ≥140 and/or diastolic blood pressure \[DBP\] ≥90 mmHg) this includes those on medications to treat hypertension
* Hypotension (resting BP of \<90/60 mmHg)
* Cancer in the last six months
* Any heart-rate-altering medications or any other medication that may modify metabolic responses
* Self-reported diabetes or use of glucose-lowering medication
* Tobacco products, including vaping, or marijuana use
* Currently pregnant
* Post-menopausal women

Specific Exclusion Criteria for Certain Stressors:

* Orthopedic limitations that would prohibit exercise or movement for exercise
* Fracture of limb to be immersed for CPT
* Open cut or sore on hand to be immersed for CPT
* Raynaud's syndrome for CPT

Where it's running

• Linda Crnic Institute for Down Syndrome, University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting

Study contacts

• Study coordinator: Sara R Sherman, PhD
• Email: sara.r.sherman@cuanschutz.edu
• Phone: 303-724-0598

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.