Vascular Inflammation in Adolescents With Type 1 Diabetes

Prevalence of Oxidative Stress, Endothelial Dysfunction, Increased Carotid Artery Intima-media Thickness (cIMT) and Biomarkers of Vascular Inflammation in Adolescents With Type-1 Diabetes Mellitus (T1DM)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00933101

Enrollment

Registered

2009-07-07

Start date

2010-01-31

Completion date

2011-06-30

Last updated

2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Type 1 Diabetes Mellitus

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to 18 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results