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Completed

NCT Number: NCT00933101

Vascular Inflammation in Adolescents With Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Arterial Occlusive Diseases Arteriosclerosis Autoimmune Diseases Cardiovascular Diseases Coronary Artery Disease Coronary Disease Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Immune System Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Determine the impact of glycemic control on vascular oxidative stress/inflammation in adolescents with Type 1 diabetes mellitus

    Time frame: 1 year

Secondary outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 7, 2009
Registry last updated
Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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