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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eugene Barrett, University of Virginia
ClinicalTrials.gov Identifier:
NCT01337947
First received: April 14, 2011
Last updated: September 26, 2014
Last verified: April 2011
  Purpose

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


Condition Intervention
Type 1 Diabetes
Drug: Definity microbubbles

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Fitness on Vascular Dysfunction in Adolescents With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • arterial vascular stiffness [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    Arterial Stiffness will be measured as follows:

    1. Pulse wave velocity (m/sec)
    2. Augmentation index ( %)


Secondary Outcome Measures:
  • nitric oxide dependent vasodilation [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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)


Enrollment: 32
Study Start Date: April 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
exercise training
12 weeks of exercise treatment/program for DM1 subjects
Drug: Definity microbubbles
Definity microbubbles are used as a contrast agent to image blood flow in skeletal muscle
Other Name: Definity

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

DM1 and healthy controls

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337947

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Eugene Barrett, MD University of Virginia
  More Information

Additional Information:
Publications:

Responsible Party: Eugene Barrett, Eugene Barrett, MD, PhD, University of Virginia
ClinicalTrials.gov Identifier: NCT01337947     History of Changes
Other Study ID Numbers: IRB- HSR #15312
Study First Received: April 14, 2011
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
Type 1 diabetes
adolescents
exercise
vascular function

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Definity
Perflutren
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014