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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01337947
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : September 29, 2014
Sponsor:
Information provided by (Responsible Party):
Eugene Barrett, University of Virginia

Tracking Information
First Submitted Date April 14, 2011
First Posted Date April 19, 2011
Last Update Posted Date September 29, 2014
Study Start Date April 2011
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2011)
arterial vascular stiffness [ Time Frame: 2 years ]
Arterial Stiffness will be measured as follows:
  1. Pulse wave velocity (m/sec)
  2. Augmentation index ( %)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 26, 2014)
nitric oxide dependent vasodilation [ Time Frame: 2 years ]
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)
Original Secondary Outcome Measures
 (submitted: April 15, 2011)
nitric oxide dependent vasodilation [ Time Frame: 2 years ]
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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population DM1 and healthy controls
Condition Type 1 Diabetes
Intervention Drug: Definity microbubbles
Definity microbubbles are used as a contrast agent to image blood flow in skeletal muscle
Other Name: Definity
Study Groups/Cohorts exercise training
12 weeks of exercise treatment/program for DM1 subjects
Intervention: Drug: Definity microbubbles
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 26, 2014)
32
Original Estimated Enrollment
 (submitted: April 15, 2011)
40
Actual Study Completion Date November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01337947
Other Study ID Numbers IRB- HSR #15312
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Eugene Barrett, University of Virginia
Study Sponsor University of Virginia
Collaborators Not Provided
Investigators
Principal Investigator: Eugene Barrett, MD University of Virginia
PRS Account University of Virginia
Verification Date April 2011