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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01337947
Enrollment
32
Registered
2011-04-19
Start date
2011-04-30
Completion date
2013-11-30
Last updated
2014-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes, adolescents, exercise, vascular function

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

Interventions

DRUGDefinity microbubbles

Definity microbubbles are used as a contrast agent to image blood flow in skeletal muscle

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
arterial vascular stiffness2 yearsArterial Stiffness will be measured as follows: 1. Pulse wave velocity (m/sec) 2. Augmentation index ( %)

Secondary

MeasureTime frameDescription
nitric oxide dependent vasodilation2 yearsNO 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026