Vascular Inflammation in Adolescents With Type 1 Diabetes
This study has been completed.
Sponsor:
Children's Mercy Hospital Kansas City
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
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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
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:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Diabetes Mellitus Diabetes Mellitus, Type 1 Inflammation Heart Diseases Cardiovascular Diseases Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013