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Clinical Trials/NCT00933101
NCT00933101
Completed
Not Applicable

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)

Children's Mercy Hospital Kansas City1 site in 1 country51 target enrollmentJanuary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes Mellitus
Sponsor
Children's Mercy Hospital Kansas City
Enrollment
51
Locations
1
Primary Endpoint
Determine the impact of glycemic control on vascular oxidative stress/inflammation in adolescents with Type 1 diabetes mellitus
Status
Completed
Last Updated
14 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
June 2011
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Children's Mercy Hospital Kansas City

Eligibility 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
  • Congenital heart disease
  • Pituitary tumor
  • Known allergy to ultrasound gel
  • Recent head injury
  • Chromosomal abnormalities

Outcomes

Primary Outcomes

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

Time Frame: 1 year

Secondary Outcomes

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

Study Sites (1)

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