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

September 26, 2014 updated by: Eugene Barrett, University of Virginia
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

DM1 and healthy controls

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • Definity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
arterial vascular stiffness
Time Frame: 2 years

Arterial Stiffness will be measured as follows:

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Eugene Barrett, MD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

April 14, 2011

First Submitted That Met QC Criteria

April 15, 2011

First Posted (Estimate)

April 19, 2011

Study Record Updates

Last Update Posted (Estimate)

September 29, 2014

Last Update Submitted That Met QC Criteria

September 26, 2014

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB- HSR #15312

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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