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Diabetes Type 1EJB046NCT02490124

The Effect of Type 1 Diabetes on Pan-Arterial Vascular Function and Insulin Sensitivity in Humans

An observational study of Diabetes Type 1, 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

Arterial vascular disease is the major cause of morbidity and mortality for Type 1 diabetic patients (DM1). Metabolic insulin resistance (metIR), even in the absence of hyperglycemia, conveys a 1.5 to 3-fold increased CVD risk in the general population. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Type 1
How many people
7 participants
Where
1 siteUnited States
Study dates
Dec 2014to Jun 2015
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 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Type 1 Diabetes Healthy Controls

Who may be able to join

  • Age 18-40
  • BMI ≤ 25
  • Healthy with no chronic illness (control group only)
  • Normal screening labs or no clinically significant values
  • DM1 subjects will have been on insulin for at least 5 years and HbA1c <9

Who cannot join

  • First degree relative with Type 1 or 2 Diabetes (for control group only)
  • Smoking presently or in the past 6 months
  • Medications that affect the vasculature (except ACE or ARB in DM1 subjects, although they will need to be off these drugs for 2 weeks prior to study).
  • Elevated LDL cholesterol > 160
  • BP <100/60 or >160/90
  • Pulse oximetry <90%
Show all 15Show fewer
  • Pregnant or breastfeeding
  • History of cardiovascular disease, cerebral vascular disease, peripheral vascular disease, liver disease
  • Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam ).
  • Known hypersensitivity to perflutren (contained in Definity)
  • For DM1 group:
  • HbA1c ≥ 9
  • Microalbuminuria
  • Retinipathy
  • Ketoacidosis within the past year.

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

Arterial vascular disease is the major cause of morbidity and mortality for Type 1 diabetic patients (DM1). Metabolic insulin resistance (metIR), even in the absence of hyperglycemia, conveys a 1.5 to 3-fold increased CVD risk in the general population. Metabolic Insulin Resistance (MetIR) has been repeatedly shown to be prevalent in adults and adolescents with DM1. MetIR in obesity and DM2 are accompanied by vascular insulin resistance (vasIR) which is characterized by impaired vasodilatory action of insulin on resistance or microvascular vessels. VasIR has not been systematically studied in DM1. We hypothesize that in young adults DM1 impairs both baseline and insulin-responsive vascular function throughout the arterial vasculature.

Read the detailed description

In our study, 20 healthy control subjects will be compared to 20 DM1 patients (18-40 yrs). We will assess function in conduit (pulse wave velocity-PWV, flow-mediated dilation-FMD and augmentation index-AI), resistance (post-ischemic flow velocity-PIFV) and heart and skeletal muscle microvascular (contrast enhanced ultrasound-CEU) vessels before and after 2 hrs of a euglycemic insulin clamp.

Conditions
Diabetes Type 1
Keywords
Diabetes Type 1, Vascular Function
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

Study groups in NCT02490124
Study groupRoleWhat they receive
Type 1 DiabeticType 1 Diabetic
Controlnormal healthy control

What is being measured

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

  1. Augmentation Index

    vascular measure

    Measured: baseline

  2. Pulse Wave Velocity

    vascular measure

    Measured: baseline

  3. Flow Mediated Dilation

    vascular measure

    Measured: Baseline

  4. Contrast Enhanced Ultrasound

    vascular measure

    Measured: baseline

  5. Augmentation Index

    vascular measure

    Measured: after 2 hour insulin clamp

  6. Pulse Wave Velocity

    vascular measure

    Measured: after 2 hour insulin clamp

  7. Flow Mediated Dilation

    vascular measure

    Measured: after 2 hour insulin clamp

  8. Contrast Enhanced Ultrasound

    vascular measure

    Measured: after 2 hour insulin clamp

Timeline

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

  1. First posted3 Jul 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

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
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02490124
Sponsor's protocol ID
17099
Acronym
EJB046
Status last verified
Jan 2016
First submitted
1 Jul 2015
Last updated
13 Jan 2016
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

  • Krolewski AS, Kosinski EJ, Warram JH, Leland OS, Busick EJ, Asmal AC, Rand LI, Christlieb AR, Bradley RF, Kahn CR. Magnitude and determinants of coronary artery disease in juvenile-onset, insulin-dependent diabetes mellitus. Am J Cardiol. 1987 Apr 1;59(8):750-5. doi: 10.1016/0002-9149(87)91086-1.

    PubMed 3825934

  • Widlansky ME, Gokce N, Keaney JF Jr, Vita JA. The clinical implications of endothelial dysfunction. J Am Coll Cardiol. 2003 Oct 1;42(7):1149-60. doi: 10.1016/s0735-1097(03)00994-x.

    PubMed 14522472

  • Schram MT, Chaturvedi N, Schalkwijk CG, Fuller JH, Stehouwer CD; EURODIAB Prospective Complications Study Group. Markers of inflammation are cross-sectionally associated with microvascular complications and cardiovascular disease in type 1 diabetes--the EURODIAB Prospective Complications Study. Diabetologia. 2005 Feb;48(2):370-8. doi: 10.1007/s00125-004-1628-8. Epub 2005 Feb 4.

    PubMed 15692810

  • Johnstone MT, Creager SJ, Scales KM, Cusco JA, Lee BK, Creager MA. Impaired endothelium-dependent vasodilation in patients with insulin-dependent diabetes mellitus. Circulation. 1993 Dec;88(6):2510-6. doi: 10.1161/01.cir.88.6.2510.

    PubMed 8080489

  • Clarkson P, Celermajer DS, Donald AE, Sampson M, Sorensen KE, Adams M, Yue DK, Betteridge DJ, Deanfield JE. Impaired vascular reactivity in insulin-dependent diabetes mellitus is related to disease duration and low density lipoprotein cholesterol levels. J Am Coll Cardiol. 1996 Sep;28(3):573-9. doi: 10.1016/0735-1097(96)82380-1.

    PubMed 8772741

  • Lockhart CJ, Agnew CE, McCann A, Hamilton PK, Quinn CE, McCall DO, Plumb RD, McClenaghan VC, McGivern RC, Harbinson MT, McVeigh GE. Impaired flow-mediated dilatation response in uncomplicated Type 1 diabetes mellitus: influence of shear stress and microvascular reactivity. Clin Sci (Lond). 2011 Aug;121(3):129-39. doi: 10.1042/CS20100448.

    PubMed 21345174

  • Boutouyrie P, Tropeano AI, Asmar R, Gautier I, Benetos A, Lacolley P, Laurent S. Aortic stiffness is an independent predictor of primary coronary events in hypertensive patients: a longitudinal study. Hypertension. 2002 Jan;39(1):10-5. doi: 10.1161/hy0102.099031.

    PubMed 11799071

  • Anderson TJ, Charbonneau F, Title LM, Buithieu J, Rose MS, Conradson H, Hildebrand K, Fung M, Verma S, Lonn EM. Microvascular function predicts cardiovascular events in primary prevention: long-term results from the Firefighters and Their Endothelium (FATE) study. Circulation. 2011 Jan 18;123(2):163-9. doi: 10.1161/CIRCULATIONAHA.110.953653. Epub 2011 Jan 3.

    PubMed 21200002

  • Schauer IE, Snell-Bergeon JK, Bergman BC, Maahs DM, Kretowski A, Eckel RH, Rewers M. Insulin resistance, defective insulin-mediated fatty acid suppression, and coronary artery calcification in subjects with and without type 1 diabetes: The CACTI study. Diabetes. 2011 Jan;60(1):306-14. doi: 10.2337/db10-0328. Epub 2010 Oct 26.

    PubMed 20978091

  • Liu J, Jahn LA, Fowler DE, Barrett EJ, Cao W, Liu Z. Free fatty acids induce insulin resistance in both cardiac and skeletal muscle microvasculature in humans. J Clin Endocrinol Metab. 2011 Feb;96(2):438-46. doi: 10.1210/jc.2010-1174. Epub 2010 Nov 3.

    PubMed 21047922

  • Laakso M, Edelman SV, Brechtel G, Baron AD. Decreased effect of insulin to stimulate skeletal muscle blood flow in obese man. A novel mechanism for insulin resistance. J Clin Invest. 1990 Jun;85(6):1844-52. doi: 10.1172/JCI114644.

    PubMed 2189893

  • Clerk LH, Vincent MA, Jahn LA, Liu Z, Lindner JR, Barrett EJ. Obesity blunts insulin-mediated microvascular recruitment in human forearm muscle. Diabetes. 2006 May;55(5):1436-42. doi: 10.2337/db05-1373.

    PubMed 16644702

  • Verma S, Buchanan MR, Anderson TJ. Endothelial function testing as a biomarker of vascular disease. Circulation. 2003 Oct 28;108(17):2054-9. doi: 10.1161/01.CIR.0000089191.72957.ED. No abstract available.

    PubMed 14581384

  • Barrett EJ, Wang H, Upchurch CT, Liu Z. Insulin regulates its own delivery to skeletal muscle by feed-forward actions on the vasculature. Am J Physiol Endocrinol Metab. 2011 Aug;301(2):E252-63. doi: 10.1152/ajpendo.00186.2011. Epub 2011 May 24.

    PubMed 21610226

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Type 1, 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 5 inclusion and 15 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 13 Jan 2016. 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?

Augmentation Index (time frame: baseline). The study lists 8 primary outcomes in all. 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 NCT02490124, which also lists 58 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 13 Jan 2016.

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