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The Effect of Type 1 Diabetes on Pan-Arterial Vascular Function and Insulin Sensitivity in Humans (EJB046)

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ClinicalTrials.gov Identifier: NCT02490124
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
Eugene Barrett, University of Virginia

Brief 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. 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.

Condition or disease
Diabetes Type 1

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.

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Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Type 1 Diabetes on Pan-Arterial Vascular Function and Insulin Sensitivity in Humans
Study Start Date : December 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Insulin

Group/Cohort
Type 1 Diabetic
Type 1 Diabetic
Control
normal healthy control



Primary Outcome Measures :
  1. Augmentation Index [ Time Frame: baseline ]
    vascular measure

  2. Pulse Wave Velocity [ Time Frame: baseline ]
    vascular measure

  3. Flow Mediated Dilation [ Time Frame: Baseline ]
    vascular measure

  4. Contrast Enhanced Ultrasound [ Time Frame: baseline ]
    vascular measure

  5. Augmentation Index [ Time Frame: after 2 hour insulin clamp ]
    vascular measure

  6. Pulse Wave Velocity [ Time Frame: after 2 hour insulin clamp ]
    vascular measure

  7. Flow Mediated Dilation [ Time Frame: after 2 hour insulin clamp ]
    vascular measure

  8. Contrast Enhanced Ultrasound [ Time Frame: after 2 hour insulin clamp ]
    vascular measure



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Type 1 Diabetes Healthy Controls
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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%
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490124


Locations
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United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Eugene J. B, MD, PhD University of Virginia

Publications:

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Responsible Party: Eugene Barrett, Professor Eugene Barrett MD PhD, University of Virginia
ClinicalTrials.gov Identifier: NCT02490124     History of Changes
Other Study ID Numbers: 17099
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016
Keywords provided by Eugene Barrett, University of Virginia:
Diabetes Type 1
Vascular Function
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs