Vascular Inflammation in Adolescents With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00933101
First received: July 2, 2009
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

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
Type 1 Diabetes Mellitus
Coronary Artery Disease

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Determine the impact of glycemic control on vascular oxidative stress/inflammation in adolescents with Type 1 diabetes mellitus [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the impact of glycemic control and vascular oxidative stress/inflammation on vascular health in adolescents with T1DM [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood


Enrollment: 51
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric Endocrinology clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933101

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

No publications provided

Responsible Party: Children's Mercy Hospital, Department of Endocrinology
ClinicalTrials.gov Identifier: NCT00933101     History of Changes
Other Study ID Numbers: 08 12-200E
Study First Received: July 2, 2009
Last Updated: June 23, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014