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Vascular Health and Risk Factors in Children With Down Syndrome

NCT04735874 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2023-08-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Adam L Ware, MD · University of Utah

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-02
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04735874 on ClinicalTrials.gov