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

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Definity microbubbles

• Registration Number: NCT01337947
• Lead Sponsor: University of Virginia

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-04
• Study Start: 2011-04
• Study First Submitted: 2011-04-14
• Study First Submitted QC: 2011-04-15
• Study First Posted: 2011-04-19
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2014-09-26
• Last Update Posted: 2014-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
exercise training	Definity microbubbles	12 weeks of exercise treatment/program for DM1 subjects

Primary Outcome Measures

Name	Time	Method
arterial vascular stiffness	2 years	Arterial Stiffness will be measured as follows: 1. Pulse wave velocity (m/sec); 2. Augmentation index ( %)

Secondary Outcome Measures

Name	Time	Method
nitric oxide dependent vasodilation	2 years	NO dependent vasodilation will be measured by: 1. Flow Mediated dilation of brachial artery (% of brachial artery diameter change); 2. Post ischemic flow velocity in brachial artery ( m/sec); 3. Forearm microvascular perfusion using contrast ultrasound ( video intensity)

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States