NCT04735874

Vascular Health and Risk Factors in Children With Down Syndrome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, multicenter, cross-sectional study to evaluate prevalence of vascular risk factors in children with Down Syndrome and to determine the association between vascular disease risk factors and objective markers of early atherosclerosis.

Conditions

• Down Syndrome
• Cardiovascular Risk Factor
• Atherosclerosis

Interventions

Type	Name	Description
OTHER	Evaluate vascular disease risk factors in children with Down Syndrome	We will determine CV disease risk profiles in children with DS at our centers. We will compare these data to published national norms of children without DS. Risk factor data will include: anthropometric measures; blood pressure; history of congenital heart disease and associated surgery, sleep apnea, hypothyroidism, and cancer; fasting blood draw \[lipid panel with subfractions (NMR), insulin, glucose, and CRP\].
OTHER	Determine the associations between cardiovascular disease risk factors and markers of early atherosclerosis in children with Down Syndrome	We will perform PWV, CIMT, and CD studies in children with DS and compare these data to available data in children without DS. We will also perform multivariable analysis of the influence of combinations of CV disease risk factors on markers of early atherosclerosis in children with DS. Hypothesis: CV disease risk factors will correlate with markers of early atherosclerosis in children with DS but the associations between risk factors and markers of early atherosclerosis will differ between children with DS vs. the general population of children.

Timeline

• Start date: 2021-02-02
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2021-02-03
• Last updated: 2023-08-14

Locations

1 site across 1 country: United States