|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00933101 |
|
Date of registration:
|
02/07/2009 |
|
Primary sponsor: |
|
|
Public title:
|
Vascular Inflammation in Adolescents With Type 1 Diabetes
|
|
Scientific 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) |
|
Date of first enrolment:
|
January 2010 |
|
Target sample size:
|
51 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00933101 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Case-Only, Time Perspective: Prospective
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Ghufran Babar, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Children's Mercy Hospital Kansas City |
| | |
|
Key inclusion & exclusion 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
Age minimum:
12 Years
Age maximum:
18 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Coronary Artery Disease
|
|
Type 1 Diabetes Mellitus
|
|
Primary Outcome(s)
|
|
Determine the impact of glycemic control on vascular oxidative stress/inflammation in adolescents with Type 1 diabetes mellitus
[Time Frame: 1 year]
|
|
Secondary Outcome(s)
|
|
To determine the impact of glycemic control and vascular oxidative stress/inflammation on vascular health in adolescents with T1DM
[Time Frame: 1 year]
|
|
Secondary ID(s)
|
|
08 12-200E
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|