Vascular Function in Adults With Down Syndrome

NCT07630207 | Recruiting

• 1 other identifier: UNLV-2025-360
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Adults with Down syndrome (Ds) are often thought to have a lower risk of heart and blood vessel disease because they tend to have lower blood pressure and fewer heart attacks than people without Ds. However, recent research suggests that heart and blood vessel diseases, including stroke, are becoming a more common cause of death in adults with Ds as life expectancy increases. Despite these findings, studies examining heart and blood vessel health in adults with Ds have produced mixed results, making it difficult to determine their true risk and whether preventive strategies are needed. This study will investigate the health of blood vessels in adults with Ds and compare the results with those of adults without Ds. Healthy blood vessels are important because they help deliver blood and oxygen throughout the body. Changes in blood vessel function and stiffness can occur with aging and may increase the risk of heart disease, stroke, kidney disease, and memory problems. The study aims to determine whether adults with Ds experience changes in blood vessel health that may place them at increased cardiovascular risk. Specifically, the study will: (1) Examine how well blood vessels function in adults with Ds; (2) Measure the stiffness of arteries in adults with Ds; (3) Compare two methods used to assess blood vessel function to determine whether a simpler exercise-based test provides results similar to a commonly used standard test. The findings may improve understanding of cardiovascular risk in adults with Ds and help guide future strategies to promote healthy aging in this population.

Conditions

Down Syndrome (Trisomy 21)

Keywords

Down Syndrome; Trisomy 21; Arterial stiffness; Endothelial function; vascular function; ultrasonography; arterial doppler

Outcome Measures

Primary Outcomes (1)

• Carotid-femoral pulse wave velocity (PWV).

  PWV (m/s) will be measured using small, non-invasive pressure-sensitive transducers that record distension waveforms over superficial arteries like the carotid and femoral artery (PulsePen® DiaTecne - Italia).

  Through study completion, on average 4 hours

Secondary Outcomes (5)

• Augmentation index

  Through study completion, on average 4 hours.

• Carotid Beta-stiffness

  Through study completion, on average 4 hours.

• Intima-Media Thickness

  Through study completion, on average 4 hours.

• Change in Blood Flow after isometric hand grip exercise.

  Through study completion, on average 4 hours.

• Change in Blood Flow after occlusion

  Through study completion, on average 4 hours.

Study Arms (2)

Down Syndrome

Adults with Down Syndrome

Control group

Age- and sex-matched adults without Down Syndrome

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The population being evaluated by the protocol consists of a convenience sample of individuals with Down syndrome (Ds) between the ages of 18 and 35 years old, and a group of controls without Ds matched for age and sex, living in the community. 24 participants will be enrolled in the study at UNLV; 12 individuals with Down syndrome and 12 individuals without Down syndrome.

You may qualify if:

• between 18 and 35 years old
• generally healthy
• sedentary (defined as being involved in less than 30 minutes of moderately-intense physical activity per day)
• Additionally, for the participants with Down syndrome:
• diagnosis of Down syndrome trisomy 21
• normal thyroid function or stable thyroid function (and medications) for at least 6 mo.

You may not qualify if:

• unresolved congenital heart disease;
• atherosclerotic or other vascular disease (such as blood clot history or clotting disorders);
• asthma or other pulmonary disease;
• hypertension (defined BP \>140/90 mmHg); blood pressure below 90/60 mmHg;
• history of pre-syncope or syncope;
• diabetes (defined as Hba1c of \>7.5% or use of glucose lowering medication);
• severe obesity (defined as BMI \>40);
• heart medications affecting heart rate, blood pressure or arterial function, including blood thinners; anti-inflammatory medication including NSAIDS;
• current smoking;
• currently pregnant or planning to become pregnant during the study period;
• currently breastfeeding;
• unable or unwilling to use an acceptable method of contraception during the study timeframe;
• positive pregnancy test at screening.

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Study Sites (1)

University of Nevada Las Vegas - UNLV

Las Vegas, Nevada, 89154, United States

RECRUITING

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Central Study Contacts

Thessa Hilgenkamp, PhD

CONTACT

(702) 8951055; thessa.hilgenkamp@unlv.edu

Andre Rocha, MSc

CONTACT

(725)587-7643; andre.rocha@unlv.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: April 9, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)