Vascular Function in Adolescent, Diabetic Children | NCT00348179

Studies
Vascular Function in Adolescent, Diabetic Children

NCT00348179

Sponsor

Children's Mercy Hospital Kansas City

Status

Completed

Last Update Posted

Jan 24, 2008Estimated

Enrollment

85Actual

Phase

Not Applicable

Conditions

Type 1 Diabetes

Interventions

Measurement of vascular function per SphymgnoCor equipment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2004

Primary Completion Date

Apr 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

Jun 30, 2006

First Submission Date that Met QC Criteria

Jul 3, 2006

First Posted Date

Jul 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2008

Last Update Posted Date

Jan 24, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

85Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Measurement of vascular function per SphymgnoCor equipment	Procedure	Pressure tonometer will be used on various vessels, non-invasive.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kurt Midyett, MD	Children's Mercy Hospital Kansas City	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Mercy Hospital		Kansas City	Missouri	64108	United States

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided