Vascular Inflammation in Adolescents With Type 1 Diabetes

Completed

• Conditions: Type 1 Diabetes Mellitus; Coronary Artery Disease

• Registration Number: NCT00933101
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief Summary

The purpose of this study is to find out if diabetes damages the blood vessels of adolescents with good diabetes control compared to adolescents with less optimal control.

Detailed Description

Many published studies reveal that adult patients with T1DM can have early, silent and more advanced vessel wall thickness than normal subjects. This is influenced by the degree of their blood sugar control. If this is happening in adolescents, we want to know what proportion of adolescent children with type 1 diabetes show signs of early blood vessel damage. We also want to learn if these signs of damage are linked to other factors such as how long someone has had diabetes, blood sugar control or individual differences because of a difference in genetic make-up.

Study Timeline

• Study First Submitted: 2009-07-02
• Study First Submitted QC: 2009-07-02
• Study First Posted: 2009-07-07
• Study Start: 2010-01
• Status Verified: 2011-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-23
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Adolescents ages 12-18 years
• Tanner stage III-V
• T1DM > 2 years
• HgbA1c <8 or >10 for previous 2 years

Exclusion Criteria

• Subjects with known history of hypercholesterolemia or family history of hypercholesterolemia
• Family history of premature cardiovascular disease
• Hypertension defined as subjects with blood pressure greater than the 90th percentile for age
• Anemia defined as Hgb <11.0 g/dl
• ADHD
• Congenital heart disease
• Pituitary tumor
• Known allergy to ultrasound gel
• Recent head injury
• Chromosomal abnormalities

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the impact of glycemic control on vascular oxidative stress/inflammation in adolescents with Type 1 diabetes mellitus	1 year

Secondary Outcome Measures

Name	Time	Method
To determine the impact of glycemic control and vascular oxidative stress/inflammation on vascular health in adolescents with T1DM	1 year

Trial Locations

Locations (1)

Children's Mercy Hospitals and Clinics; 🇺🇸 Kansas City, Missouri, United States