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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02490124
Acronym
EJB046
Enrollment
7
Registered
2015-07-03
Start date
2014-12-31
Completion date
2015-06-30
Last updated
2016-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Type 1

Keywords

Diabetes Type 1, Vascular Function

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.

Interventions

None listed

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Augmentation Indexbaselinevascular measure
Pulse Wave Velocitybaselinevascular measure
Flow Mediated DilationBaselinevascular measure
Contrast Enhanced Ultrasoundbaselinevascular measure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026