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Vascular Function in Adolescent, Diabetic Children

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Measurement of vascular function per SphymgnoCor equipment
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Type 1 Diabetes focused on measuring Vascular abnormalities, Type 1 diabetes, Healthy control subjects

Eligibility Criteria

12 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Children's Mercy Hospital

Outcomes

Primary Outcome Measures

Vascular abnormalities as measured by the SyphmgnoCor equipment

Secondary Outcome Measures

Full Information

First Posted
June 30, 2006
Last Updated
January 23, 2008
Sponsor
Children's Mercy Hospital Kansas City
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1. Study Identification

Unique Protocol Identification Number
NCT00348179
Brief Title
Vascular Function in Adolescent, Diabetic Children
Official Title
Vascular Function in Adolescent, Diabetic Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Mercy Hospital Kansas City

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objectives of this investigator initiated study are to: Determine if and when vascular abnormalities occur during early adolescence 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Vascular abnormalities, Type 1 diabetes, Healthy control subjects

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Measurement of vascular function per SphymgnoCor equipment
Intervention Description
Pressure tonometer will be used on various vessels, non-invasive.
Primary Outcome Measure Information:
Title
Vascular abnormalities as measured by the SyphmgnoCor equipment
Time Frame
End of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt Midyett, MD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vascular Function in Adolescent, Diabetic Children

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