Vascular Inflammation in Adolescents With Type 1 Diabetes

Children's Mercy Hospital Kansas City

Status: Completed

Conditions: Coronary Artery Disease; Type 1 Diabetes Mellitus

Study type: Observational

Funder types: Other

Identifiers

NCT00933101

08 12-200E

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

51 participants in 2 patient groups

HgbA1c <8

Description:

Adolescents with HgbA1c \< or equal to 8% for the previous 12 months

HgbA1c >10

Description:

Adolescents with HgbA1c \> or equal to 10% for previous 12 months