Vascular Inflammation in Adolescents With Type 1 Diabetes

Coronary Artery Disease Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933101
• Other study ID #: 08 12-200E
• Status: Completed
• Phase: N/A
• First received: July 2, 2009
• Last updated: June 23, 2011
• Start date: January 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Myocardial Ischemia
• Type 1 Diabetes Mellitus

Locations

Country	Name	City	State
United States	Children's Mercy Hospitals and Clinics	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the impact of glycemic control on vascular oxidative stress/inflammation in adolescents with Type 1 diabetes mellitus		1 year	No
Secondary	To determine the impact of glycemic control and vascular oxidative stress/inflammation on vascular health in adolescents with T1DM		1 year	No