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OpenTrials
Completed

NCT Number: NCT01337947

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

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Behavior Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Virginia

Charlottesville, Virginia, 22903, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Definity microbubbles

Drug

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

Other names: Definity

Primary outcomes

  1. arterial vascular stiffness

    Time frame: 2 years

    Arterial Stiffness will be measured as follows:

    • Pulse wave velocity (m/sec)
    • Augmentation index ( %)

Secondary outcomes

  1. nitric oxide dependent vasodilation

    Time frame: 2 years

    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)

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 19, 2011
Registry last updated
Sep 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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