Vascular Function in Adults With Down Syndrome
ConditionDown Syndrome (Trisomy 21)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-35
SponsorUniversity of Nevada, Las Vegas
About this trial
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 (BP) 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
diagnosis of Down syndrome trisomy 21
Disqualifiers
unresolved congenital heart disease;
atherosclerotic or other vascular disease (such as blood clot history or clotting disorders);
asthma or other pulmonary disease;
hypertension (defined as BP >140/90 mmHg); blood pressure below 90/60 mmHg;
Trial 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 control participants without Ds matched for age and sex, living in the community. 43 participants will be enrolled in the study at UNLV: 23 individuals with Down syndrome and 23 individuals without Down syndrome.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
46 Participants
are grouped into 2 trial groupsGroup A: Down Syndrome
Group B: Control group
Trial outcomes
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).
Time frame
Through study completion, on average 4 hoursSecondary outcomes
1
Augmentation index
Defined as the ratio of Augmentation Pressure (AP) to the total Pulse Pressure (PP), expressed as %. It will be measured using small, non-invasive pressure-sensitive transducers that record distension waveforms over superficial arteries (PulsePen® DiaTecne - Italia).
Time frame
Through study completion, on average 4 hours.2
Carotid Beta-stiffness
The carotid Beta-stiffness index is a unitless measurement. It quantifies the intrinsic stiffness of the common carotid artery using high-definition ultrasound (Hitachi Arietta 70 system, Tokyo, Japan).
Time frame
Through study completion, on average 4 hours.3
Intima-Media Thickness
An ultrasound-based assessment of intima-media thickness (IMT) for the carotid artery. Thickness will be calculated as the distance (mm) from the leading edge of the intima to the beginning of the adventitial layer of the top and bottom walls.
Time frame
Through study completion, on average 4 hours.4
Change in Blood Flow after isometric hand grip exercise.
Participants will perform a 2-minute isometric hand grip exercise at 30% of MVC. Brachial artery blood flow (mL/min) will be assessed using high-resolution ultrasonography (Arietta 70, Hitachi, Tokyo, Japan) and expressed as a percentage of baseline measurements, normalized to forearm lean mass.
Time frame
Through study completion, on average 4 hours.Sponsors and contacts
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Source ClinicalTrials.gov