The Impact of Fitness on Vascular Dysfunction in Adolescents With Type 1 Diabetes

Study Overview
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Brief Summary
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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

Official Title
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The Impact of Fitness on Vascular Dysfunction in Adolescents With Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Definity microbubbles


Participation Criteria
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Eligibility Criteria
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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) Two additional outpatient visits (one requires blood draw) 12 weeks of an exercise program (5 days per week, 3 of them here at UVA) Maintain healthy diet for those 12 weeks-you will have diet instruction Repeat outpatient admission as described above Exclusion Criteria: under 12 or over 18 years of age medication that could affect the blood vessels smoker above average BMI chronic illness other than DM1

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| exercise training<br>12 weeks of exercise treatment/program for DM1 subjects | Drug: Definity microbubbles<br>* Definity microbubbles are used as a contrast agent to image blood flow in skeletal muscle<br>* Other names: Definity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial vascular stiffness | Arterial Stiffness will be measured as follows: Pulse wave velocity (m/sec) Augmentation index ( %) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nitric oxide dependent vasodilation | NO dependent vasodilation will be measured by: Flow Mediated dilation of brachial artery (% of brachial artery diameter change) Post ischemic flow velocity in brachial artery ( m/sec) Forearm microvascular perfusion using contrast ultrasound ( video intensity) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, vascular function, Type 1 diabetes, adolescents