Vascular Function in Adolescent, Diabetic Children

Type 1 Diabetes Clinical Trial

Official title:

Vascular Function in Adolescent, Diabetic Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348179
• Other study ID #: 04 04-036E
• Status: Completed
• Phase: N/A
• First received: June 30, 2006
• Last updated: January 23, 2008
• Start date: April 2004
• Est. completion date: April 2007

Study information

• Verified date: April 2007
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 14 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Procedure:
• Measurement of vascular function per SphymgnoCor equipment
Pressure tonometer will be used on various vessels, non-invasive.

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular abnormalities as measured by the SyphmgnoCor equipment		End of study	No