Clinical trial NCT01337947: The Impact of Fitness on Vascular Dysfunction in Adolescents With Type 1 Diabetes
Official title: The Impact of Fitness on Vascular Dysfunction in Adolescents With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
adolescents
exercise
vascular function
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2011-04-19
Enrollment: 32
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: DM1 and healthy controls

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


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)
* 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

Primary outcomes:
measure: arterial vascular stiffness
timeFrame: 2 years
Secondary outcomes:
measure: nitric oxide dependent vasodilation
timeFrame: 2 years
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Eugene Barrett, MD
role: PRINCIPAL_INVESTIGATOR
References:
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