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

January 12, 2016 updated by: Eugene Barrett, University of Virginia
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

7

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 1 Diabetes Healthy Controls

Description

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.

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
Type 1 Diabetic
Control
normal healthy control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Augmentation Index
Time Frame: baseline
vascular measure
baseline
Pulse Wave Velocity
Time Frame: baseline
vascular measure
baseline
Flow Mediated Dilation
Time Frame: Baseline
vascular measure
Baseline
Contrast Enhanced Ultrasound
Time Frame: baseline
vascular measure
baseline
Augmentation Index
Time Frame: after 2 hour insulin clamp
vascular measure
after 2 hour insulin clamp
Pulse Wave Velocity
Time Frame: after 2 hour insulin clamp
vascular measure
after 2 hour insulin clamp
Flow Mediated Dilation
Time Frame: after 2 hour insulin clamp
vascular measure
after 2 hour insulin clamp
Contrast Enhanced Ultrasound
Time Frame: after 2 hour insulin clamp
vascular measure
after 2 hour insulin clamp

Collaborators and Investigators

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

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Eugene J. B, MD, PhD, 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

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

December 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 1, 2015

First Submitted That Met QC Criteria

July 2, 2015

First Posted (Estimate)

July 3, 2015

Study Record Updates

Last Update Posted (Estimate)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17099

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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