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)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Type 1 Diabetes Mellitus

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 Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric Endocrinology clinic

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HgbA1c <8; Adolescents with HgbA1c < or equal to 8% for the previous 12 months
HgbA1c >10; Adolescents with HgbA1c > or equal to 10% for previous 12 months

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Investigators: Principal Investigator: Ghufran Babar, MD, Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: July 2, 2009
• First Submitted That Met QC Criteria: July 2, 2009
• First Posted (Estimate): July 7, 2009

Study Record Updates

• Last Update Posted (Estimate): June 27, 2011
• Last Update Submitted That Met QC Criteria: June 23, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Autoimmune Diseases; Endocrine System Diseases; Coronary Disease; Coronary Artery Disease; Diabetes Mellitus; Diabetes Mellitus, Type 1; Inflammation
• Other Study ID Numbers: 08 12-200E