Vascular Inflammation in Adolescents With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00933101
Recruitment Status : Completed
First Posted : July 7, 2009
Last Update Posted : June 27, 2011
Information provided by:
Children's Mercy Hospital Kansas City

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.

Condition or disease
Type 1 Diabetes Mellitus Coronary Artery Disease

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
Actual Enrollment : 51 participants
Observational Model: Case-Only
Time Perspective: Prospective
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)
Study Start Date : January 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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

Primary Outcome Measures :
  1. Determine the impact of glycemic control on vascular oxidative stress/inflammation in adolescents with Type 1 diabetes mellitus [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To determine the impact of glycemic control and vascular oxidative stress/inflammation on vascular health in adolescents with T1DM [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Whole blood

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric Endocrinology clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00933101

United States, Missouri
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Principal Investigator: Ghufran Babar, MD Children's Mercy Hospital Kansas City

Responsible Party: Children's Mercy Hospital, Department of Endocrinology Identifier: NCT00933101     History of Changes
Other Study ID Numbers: 08 12-200E
First Posted: July 7, 2009    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Autoimmune Diseases
Immune System Diseases