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

This study is currently recruiting participants.
Verified April 2011 by University of Virginia
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT01337947
First received: April 14, 2011
Last updated: April 15, 2011
Last verified: April 2011
History of Changes
  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
 Other: exercise and diet intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Fitness on Vascular Dysfunction in Adolescents With Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

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 dialtion 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)


Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
exercise and diet intervention Other: exercise and diet intervention
Exercise consult with an exercise physiologist and diet consult with a dietician will be provided.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337947

Contacts
Contact: Linda Jahn, RN, MEd 434-924-1134 las6e@virginia.edu
Contact: Lee Hartline, MEd lmh9d@virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Linda Jahn, RN, MEd     434-924-1134     las6e@virginia.edu    
Contact: Lee Hartline, MEd         lmh9d@virginia.edu    
Principal Investigator: Eugene J Barrett, MD            
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Eugene Barrett, MD University of Virginia
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Eugene J. Barrett MD, University of Virginia
ClinicalTrials.gov Identifier: NCT01337947     History of Changes
Other Study ID Numbers: 15312
Study First Received: April 14, 2011
Last Updated: April 15, 2011
Health Authority: United States: Food and Drug Administration
United States: University of Virginia

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013