The Impact of Fitness on Vascular Dysfunction in Adolescents With Type 1 Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Definity microbubbles
- Conditions
- Type 1 Diabetes
- Sponsor
- University of Virginia
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- arterial vascular stiffness
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The principal hypothesis of this study is that the micro and macro vasculature of young diabetes mellitus type 1 (DM1) patients is particularly susceptible to atherogenic factors which cause vascular dysfunction at multiple levels of the arterial vasculature and that this dysfunction is demonstrable using state-of-the-art ultrasound methods. The investigators further hypothesize that interventions, such as exercise, that are readily integrated into the daily life of individuals with DM1 can mitigate or reverse these early vascular changes and thereby diminish the otherwise predictable longer-term development of cardiovascular disease (CVD) in type 1 DM
Investigators
Eugene Barrett
Eugene Barrett, MD, PhD
University of Virginia
Eligibility Criteria
Inclusion Criteria
- •You may be eligible if you are:
- •Male or female, 12-18 years of age
- •Healthy, no chronic illness other than DM1
- •No medications that would affect the blood vessels
- •Non-smoker
- •Normal height and weight
- •Requirements for both groups (study 1)
- •Two outpatient visits lasting \~1 to 1 ½ hours
- •1 outpatient admission lasting \~ 10 hrs
- •Most visits require blood draws Requirements for second part of study for DM1 group (study 2)
Exclusion Criteria
- •under 12 or over 18 years of age
- •medication that could affect the blood vessels
- •above average BMI
- •chronic illness other than DM1
Arms & Interventions
exercise training
12 weeks of exercise treatment/program for DM1 subjects
Intervention: Definity microbubbles
Outcomes
Primary Outcomes
arterial vascular stiffness
Time Frame: 2 years
Arterial Stiffness will be measured as follows: 1. Pulse wave velocity (m/sec) 2. Augmentation index ( %)
Secondary Outcomes
- nitric oxide dependent vasodilation(2 years)