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

Completed

• Conditions: Diabetes Type 1

• Registration Number: NCT02490124
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-02
• Study First Posted: 2015-07-03
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulse Wave Velocity	after 2 hour insulin clamp	vascular measure
Flow Mediated Dilation	after 2 hour insulin clamp	vascular measure
Augmentation Index	after 2 hour insulin clamp	vascular measure
Contrast Enhanced Ultrasound	after 2 hour insulin clamp	vascular measure

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States