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Completed

NCT Number: NCT02490124

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

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.

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Key information

Conditions

Diabetes Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Virginia

Charlottesville, Virginia, 22903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Acronym: EJB046

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 3, 2015
Registry last updated
Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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