## Protocol Section
### Identification Module
**NCT ID:** NCT00348179

**Brief Title:** Vascular Function in Adolescent, Diabetic Children

**Official Title:** Vascular Function in Adolescent, Diabetic Children

#### Organization Study ID Info
**ID:** 04 04-036E
#### Organization
**Class:** OTHER
**Full Name:** Children's Mercy Hospital Kansas City
### Status Module
#### Completion Date
**Date:** 2007-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2008-01-24

**Type:** ESTIMATED

**Last Update Submit Date:** 2008-01-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-04

**Type:** ACTUAL

#### Start Date
**Date:** 2004-04

**Status Verified Date:** 2007-04

#### Study First Post Date
**Date:** 2006-07-04
**Type:** ESTIMATED
**Study First Submit Date:** 2006-06-30
**Study First Submit QC Date:** 2006-07-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Children's Mercy Hospital Kansas City

#### Responsible Party

**Old Name Title:** Kurt Midyett

**Old Organization:** Children's Mercy Hospitals and Clinics

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Type 1 Diabetes

**Keywords:**

- Vascular abnormalities

- Type 1 diabetes

- Healthy control subjects

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 85

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

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

**Name:** Measurement of vascular function per SphymgnoCor equipment

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Vascular abnormalities as measured by the SyphmgnoCor equipment

**Time Frame:** End of study

### 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

**Healthy Volunteers:** True

**Maximum Age:** 14 Years

**Minimum Age:** 12 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kansas City

**Country:** United States

**Facility:** Children's Mercy Hospital

**State:** Missouri

**Zip:** 64108

#### Overall Officials

**Official 1:**

**Affiliation:** Children's Mercy Hospital Kansas City

**Name:** Kurt Midyett, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M7117

- Name: Diabetes Mellitus, Type 1

- Relevance: HIGH

- As Found: Type 1 Diabetes

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003922

- Term: Diabetes Mellitus, Type 1

### Misc Info Module

- Version Holder: 2024-05-24
