Vascular Function in Adolescent, Diabetic Children

January 23, 2008 updated by: Children's Mercy Hospital Kansas City

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vascular abnormalities as measured by the SyphmgnoCor equipment
Time Frame: End of study
End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Investigators

  • Principal Investigator: Kurt Midyett, MD, Children's Mercy Hospital Kansas City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

June 30, 2006

First Submitted That Met QC Criteria

July 3, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

January 24, 2008

Last Update Submitted That Met QC Criteria

January 23, 2008

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04 04-036E

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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