Vascular Inflammation in Adolescents With Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 1 Diabetes Mellitus Coronary Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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HgbA1c <8

Adolescents with HgbA1c \< or equal to 8% for the previous 12 months

No interventions assigned to this group

HgbA1c >10

Adolescents with HgbA1c \> or equal to 10% for previous 12 months

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No