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Type 1 DiabetesNCT01337947

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

An observational study of Type 1 Diabetes, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Type 1 Diabetes
What is being tested?
Definity microbubbles
How many people
32 participants
Where
1 siteUnited States
Study dates
Apr 2011to Nov 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: DM1 and healthy controls

Who may be able to join

  • 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)
Show all 13Show fewer
  • 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

Who cannot join

  • under 12 or over 18 years of age
  • medication that could affect the blood vessels
  • smoker
  • above average BMI
  • chronic illness other than DM1

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Virginia

    Charlottesville, Virginia, 22903

Other trials in United States

About this study

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

Conditions
Type 1 Diabetes
Being tested
Definity microbubbles
Keywords
Type 1 diabetes, adolescents, exercise, vascular function
Medical subject headings
Diabetes Mellitus, Type 1, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Definity microbubblesDrug

    Also called Definity

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

Study groups in NCT01337947
Study groupRoleWhat they receive
exercise training12 weeks of exercise treatment/program for DM1 subjects
Receives: Drug: Definity microbubbles

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. arterial vascular stiffness

    Arterial Stiffness will be measured as follows:

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

    Measured: 2 years

Secondary outcomes (1)

  1. nitric oxide dependent vasodilation

    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)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01337947
Sponsor's protocol ID
IRB- HSR #15312
Status last verified
Apr 2011
First submitted
14 Apr 2011
Last updated
29 Sep 2014
Results posted
No
Data monitoring committee
No

Publications

  • Libby P, Nathan DM, Abraham K, Brunzell JD, Fradkin JE, Haffner SM, Hsueh W, Rewers M, Roberts BT, Savage PJ, Skarlatos S, Wassef M, Rabadan-Diehl C; National Heart, Lung, and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Report of the National Heart, Lung, and Blood Institute-National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Circulation. 2005 Jun 28;111(25):3489-93. doi: 10.1161/CIRCULATIONAHA.104.529651. No abstract available.

    PubMed 15983263

  • Soedamah-Muthu SS, Fuller JH, Mulnier HE, Raleigh VS, Lawrenson RA, Colhoun HM. High risk of cardiovascular disease in patients with type 1 diabetes in the U.K.: a cohort study using the general practice research database. Diabetes Care. 2006 Apr;29(4):798-804. doi: 10.2337/diacare.29.04.06.dc05-1433.

    PubMed 16567818

  • Brown A, Reynolds LR, Bruemmer D. Intensive glycemic control and cardiovascular disease: an update. Nat Rev Cardiol. 2010 Jul;7(7):369-75. doi: 10.1038/nrcardio.2010.35. Epub 2010 Apr 20.

    PubMed 20404853

  • Mahmud FH, Van Uum S, Kanji N, Thiessen-Philbrook H, Clarson CL. Impaired endothelial function in adolescents with type 1 diabetes mellitus. J Pediatr. 2008 Apr;152(4):557-62. doi: 10.1016/j.jpeds.2007.08.044. Epub 2007 Nov 5.

    PubMed 18346515

  • Devaraj S, Cheung AT, Jialal I, Griffen SC, Nguyen D, Glaser N, Aoki T. Evidence of increased inflammation and microcirculatory abnormalities in patients with type 1 diabetes and their role in microvascular complications. Diabetes. 2007 Nov;56(11):2790-6. doi: 10.2337/db07-0784. Epub 2007 Aug 8.

    PubMed 17686944

  • Jarvisalo MJ, Jartti L, Nanto-Salonen K, Irjala K, Ronnemaa T, Hartiala JJ, Celermajer DS, Raitakari OT. Increased aortic intima-media thickness: a marker of preclinical atherosclerosis in high-risk children. Circulation. 2001 Dec 11;104(24):2943-7. doi: 10.1161/hc4901.100522.

    PubMed 11739310

  • Galkina E, Ley K. Immune and inflammatory mechanisms of atherosclerosis (*). Annu Rev Immunol. 2009;27:165-97. doi: 10.1146/annurev.immunol.021908.132620.

    PubMed 19302038

  • Suwaidi JA, Hamasaki S, Higano ST, Nishimura RA, Holmes DR Jr, Lerman A. Long-term follow-up of patients with mild coronary artery disease and endothelial dysfunction. Circulation. 2000 Mar 7;101(9):948-54. doi: 10.1161/01.cir.101.9.948.

    PubMed 10704159

  • Heitzer T, Schlinzig T, Krohn K, Meinertz T, Munzel T. Endothelial dysfunction, oxidative stress, and risk of cardiovascular events in patients with coronary artery disease. Circulation. 2001 Nov 27;104(22):2673-8. doi: 10.1161/hc4601.099485.

    PubMed 11723017

  • Fichtlscherer S, Breuer S, Zeiher AM. Prognostic value of systemic endothelial dysfunction in patients with acute coronary syndromes: further evidence for the existence of the "vulnerable" patient. Circulation. 2004 Oct 5;110(14):1926-32. doi: 10.1161/01.CIR.0000143378.58099.8C. Epub 2004 Sep 27.

    PubMed 15451794

  • Vincent MA, Clerk LH, Lindner JR, Price WJ, Jahn LA, Leong-Poi H, Barrett EJ. Mixed meal and light exercise each recruit muscle capillaries in healthy humans. Am J Physiol Endocrinol Metab. 2006 Jun;290(6):E1191-7. doi: 10.1152/ajpendo.00497.2005.

    PubMed 16682488

  • Keske MA, Clerk LH, Price WJ, Jahn LA, Barrett EJ. Obesity blunts microvascular recruitment in human forearm muscle after a mixed meal. Diabetes Care. 2009 Sep;32(9):1672-7. doi: 10.2337/dc09-0206. Epub 2009 Jun 1.

    PubMed 19487636

  • Nadeau KJ, Regensteiner JG, Bauer TA, Brown MS, Dorosz JL, Hull A, Zeitler P, Draznin B, Reusch JE. Insulin resistance in adolescents with type 1 diabetes and its relationship to cardiovascular function. J Clin Endocrinol Metab. 2010 Feb;95(2):513-21. doi: 10.1210/jc.2009-1756. Epub 2009 Nov 13.

    PubMed 19915016

  • Woo KS, Chook P, Yu CW, Sung RY, Qiao M, Leung SS, Lam CW, Metreweli C, Celermajer DS. Effects of diet and exercise on obesity-related vascular dysfunction in children. Circulation. 2004 Apr 27;109(16):1981-6. doi: 10.1161/01.CIR.0000126599.47470.BE. Epub 2004 Apr 5.

    PubMed 15066949

  • Selvin E, Bolen S, Yeh HC, Wiley C, Wilson LM, Marinopoulos SS, Feldman L, Vassy J, Wilson R, Bass EB, Brancati FL. Cardiovascular outcomes in trials of oral diabetes medications: a systematic review. Arch Intern Med. 2008 Oct 27;168(19):2070-80. doi: 10.1001/archinte.168.19.2070.

    PubMed 18955635

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

arterial vascular stiffness (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01337947, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2014.

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