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Vascular Function in Adolescent, Diabetic Children

Vascular Function in Adolescent, Diabetic Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00348179
Enrollment
85
Registered
2006-07-04
Start date
2004-04-30
Completion date
2007-04-30
Last updated
2008-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Vascular abnormalities, Type 1 diabetes, Healthy control subjects

Brief summary

The objectives of this investigator initiated study are to: 1. Determine if and when vascular abnormalities occur during early adolescence 2. Determine if poor diabetic control is related to vascular abnormalities. The development of vascular plaques and vascular contractility will be assessed through the use of the SyphmgnoCor equipment.

Detailed description

Up to 85 Type 1 diabetic and healthy controls, 12-14 years of age, will be recruited for the study. Once the Permission/Assent form has been completed, a cuff will be applied to the arm and the pressure tonometer will be used on various vessels. Cardiovascular data will be recorded. The procedure is non-invasive, will last approximately 10 minutes and will be performed during a routine clinic visit. Onset of diabetes and level of diabetic control as measured by the most recent Hbg A1c (relative to the study visit) will be obtained from the medical record. Microalbumin levels covering the prior 12 months will be collected from the medical record of diabetic subjects.

Interventions

PROCEDUREMeasurement of vascular function per SphymgnoCor equipment

Pressure tonometer will be used on various vessels, non-invasive.

Sponsors

Children's Mercy Hospital Kansas City
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 14 Years
Healthy volunteers
Yes

Inclusion criteria

* Boys and girls ages 12-14 years who have Type 1 diabetes or are healthy controls

Exclusion criteria

* Children and adolescents who do not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
Vascular abnormalities as measured by the SyphmgnoCor equipmentEnd of study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026