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

Completed

Conditions studied: Diabetes Type 1

In brief

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.

Key facts

Study ID

NCT02490124

Run by

University of Virginia

People needed

7

Starts

2014-12-01

Expected to finish

2015-06-01

Last updated by the study team

2016-01-13

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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